Exercise and Stress Management Post Autologous and Allogeneic Transplant (BMT CTN 0902)

• Sponsor: Medical College of Wisconsin (Other)
• Overall Status: Completed
• CT.gov ID: NCT01278927
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH), Blood and Marrow Transplant Clinical Trials Network (Other), National Cancer Institute (NCI) (NIH), National Marrow Donor Program (Other)
• Enrollment: 711
• Locations: 19
• Arms: 4
• Duration (Months): 46
• Patients Per Site: 37.4
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This is a Phase III, randomized, unblinded, multicenter, prospective comparative study. The purpose of this study is to test whether exercise or stress management training delivered to autologous and allogeneic hematopoietic cell transplantation (HCT) patients prior to transplantation can improve functional status and the transplant experience.

Condition or Disease	Intervention/Treatment	Phase
Physiological Stress	Behavioral: Exercise; Behavioral: Stress Management; Behavioral: Exercise and Stress Management; Other: Standard Care	N/A

Detailed Description

Background:

The adverse effects of hematopoietic cell transplantation (HCT) on short and long term quality of life are well documented. Patients experience numerous aversive symptoms (e.g., nausea, fatigue, and sleep disturbance) that are accompanied by declines in physical and mental well-being. Although most longitudinal studies show return to baseline functioning for the majority of patients, it may take 6 to 12 months or longer to reach this goal. Clinical trials have shown that training in stress management techniques and participation in formal exercise programs each offered in isolation are effective in improving quality of life in patients receiving standard-dose chemotherapy and HCT. Review of these studies suggests that stress management interventions primarily improve mental health outcomes and nausea. The impact of exercise training interventions is more variable; most studies report physical health benefits, with some studies also reporting mental health benefits. Small studies suggest that combining stress management training and exercise are feasible and well-tolerated, but whether the combination provides an additive or synergistic impact on quality of life outcomes has not been directly investigated.

Design Narrative:

The protocol is designed as a factorial trial with two interventions, exercise and stress management, which results in four treatment arms: standard care, exercise only, stress management only and the combination of exercise and stress management. The primary objective of this randomized phase III trial is to test the ability of exercise training or stress management training to improve physical and mental functioning at Day 100 post hematopoietic cell transplantation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 711 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Phase III Randomized, Multicenter Trial Testing Whether Exercise or Stress Management Improves Functional Status and Symptoms of Autologous and Allogeneic Recipients (BMT CTN #0902)
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Exercise Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.	Behavioral: Exercise; Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.; Other Names: Physical activities Musculoskeletal Exertian level
Active Comparator: Stress Management Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.	Behavioral: Stress Management; Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.; Other Names: Active relaxation Deep breathing Positive thinking Relaxing
Active Comparator: Exercise and Stress Management Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.	Behavioral: Exercise and Stress Management; Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.; Other Names: Physical and emotional relaxation Active relaxation
Other: Standard Care Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).	Other: Standard Care; Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.; Other Names: General care Psychosocial care

Outcome Measures

Primary Outcome Measures

1. Functional Status [100 days]

   To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.

Secondary Outcome Measures

1. Symptoms [100 days]

   Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.

2. Cancer and Treatment Distress (CTXD) [100 days]

   Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.

3. The Pittsburgh Sleep Quality Index (PSQI) [100 days]

   The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.

4. Nausea [100 days]

   Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.

5. Days of Hospitalization [100 days]

   The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.

6. SF-36 Late Outcomes [6 months]

   The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.

7. Survival [6 months and 1 year]

   Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age 18 years or older

• Able to speak and read English

• Able to exercise at low to moderate intensity - adequate cardiopulmonary reserve, as judged by self-reported ability to walk up one flight of stairs, no requirement for supplemental oxygen, and physician judgment

• Willing and able to provide informed consent.

• Stated willingness to comply with study procedures and reporting requirements

• Planned autologous or allogeneic transplantation within 6 weeks.

Exclusion Criteria:

• Orthopedic, neurologic or other problems which prevent safe ambulation and protocol adherence

• Participation in another clinical trial with quality of life or functional status as a primary endpoint

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope National Medical Center	Duarte	California	United States	91010
2	University of Florida College of Medicine	Gainesville	Florida	United States	32610
3	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33624
4	Emory University	Atlanta	Georgia	United States	30322
5	Blood & Marrow Transplant Program at Northside Hospital	Atlanta	Georgia	United States	30342
6	Rush University Medical Center	Chicago	Illinois	United States	60612
7	University of Michigan Medical Center	Ann Arbor	Michigan	United States	48105-2967
8	Karmanos Cancer Institute	Detroit	Michigan	United States	48201
9	University of Minnesota	Minneapolis	Minnesota	United States	55455
10	Washington University, Barnes Jewish Hospital	Saint Louis	Missouri	United States	63110
11	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-7680
12	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10174
13	University Hospitals of Cleveland/Case Western	Cleveland	Ohio	United States	44106
14	Oregon Health & Science University	Portland	Oregon	United States	97239-3098
15	Fox Chase, Temple University	Philadelphia	Pennsylvania	United States	19111
16	Medical University of South Carolina	Charleston	South Carolina	United States	29425
17	Baylor College of Medicine/The Methodist Hospital	Houston	Texas	United States	77030
18	Virginia Commonwealth University, MCV Hospital	Richmond	Virginia	United States	23298
19	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109

Sponsors and Collaborators

• Medical College of Wisconsin
• National Heart, Lung, and Blood Institute (NHLBI)
• Blood and Marrow Transplant Clinical Trials Network
• National Cancer Institute (NCI)
• National Marrow Donor Program

Investigators

• Study Director: Mary Horowitz, MD, Center for International Blood and Marrow Transplant Research

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Blood and Marrow Transplant Clinical Trials Network (BMT CTN)
• National Marrow Donor Program

Publications

None provided.

• Responsible Party: Medical College of Wisconsin
• ClinicalTrials.gov Identifier: NCT01278927
• Other Study ID Numbers: BMTCTN0902; U01HL069294; BMT CTN 0902; 5U24CA076518
• First Posted: Jan 19, 2011
• Last Update Posted: Apr 18, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Medical College of Wisconsin: exercise; stress management; post transplant; physical and emotional relaxation

Study Results

Participant Flow

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Period Title: Overall Study
STARTED	180	178	178	175
COMPLETED	180	178	178	175
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care	Total
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.	Total of all reporting groups
Overall Participants	180	178	178	175	711
Age, Customized (participants) [Number]
<=40 years	26 14.4%	21 11.8%	26 14.6%	27 15.4%	100 14.1%
41-<65 years	105 58.3%	123 69.1%	118 66.3%	111 63.4%	457 64.3%
>=65 years	49 27.2%	34 19.1%	34 19.1%	37 21.1%	154 21.7%
Sex: Female, Male (Count of Participants)
Female	68 37.8%	78 43.8%	78 43.8%	82 46.9%	306 43%
Male	112 62.2%	100 56.2%	100 56.2%	93 53.1%	405 57%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 3.9%	11 6.2%	11 6.2%	6 3.4%	35 4.9%
Not Hispanic or Latino	172 95.6%	167 93.8%	167 93.8%	167 95.4%	673 94.7%
Unknown or Not Reported	1 0.6%	0 0%	0 0%	2 1.1%	3 0.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.6%	0 0%	0 0%	1 0.1%
Asian	3 1.7%	4 2.2%	2 1.1%	2 1.1%	11 1.5%
Native Hawaiian or Other Pacific Islander	1 0.6%	0 0%	1 0.6%	1 0.6%	3 0.4%
Black or African American	14 7.8%	17 9.6%	13 7.3%	16 9.1%	60 8.4%
White	162 90%	152 85.4%	160 89.9%	152 86.9%	626 88%
More than one race	0 0%	1 0.6%	2 1.1%	3 1.7%	6 0.8%
Unknown or Not Reported	0 0%	3 1.7%	0 0%	1 0.6%	4 0.6%
Karnofsky Performance-status Score (participants) [Number]
>=90%	112 62.2%	111 62.4%	94 52.8%	102 58.3%	419 58.9%
70%-80%	65 36.1%	64 36%	76 42.7%	68 38.9%	273 38.4%
50%-60%	2 1.1%	1 0.6%	3 1.7%	4 2.3%	10 1.4%
Missing/Not done	1 0.6%	2 1.1%	5 2.8%	1 0.6%	9 1.3%
Disease (participants) [Number]
AML/ANLL/ALL	42 23.3%	47 26.4%	40 22.5%	42 24%	171 24.1%
CML	5 2.8%	5 2.8%	2 1.1%	2 1.1%	14 2%
MDS/MPS	19 10.6%	16 9%	15 8.4%	13 7.4%	63 8.9%
MM/PCD	50 27.8%	44 24.7%	45 25.3%	57 32.6%	196 27.6%
Lymphoma	54 30%	60 33.7%	66 37.1%	50 28.6%	230 32.3%
CLL/SLL	5 2.8%	3 1.7%	5 2.8%	7 4%	20 2.8%
Solid Tumors	0 0%	1 0.6%	0 0%	1 0.6%	2 0.3%
SAA	3 1.7%	2 1.1%	2 1.1%	2 1.1%	9 1.3%
Other Disease	1 0.6%	0 0%	0 0%	0 0%	1 0.1%
Missing	1 0.6%	0 0%	3 1.7%	1 0.6%	5 0.7%

Outcome Measures

1. Secondary Outcome

Title	Symptoms
Description	Patients will complete the MOS 36-Item Short Form (SF-36), a widely used self-report measure designed to assess perceived health and functioning, contains eight scales: Physical Functioning (PF), Role-Physical (R-P); Bodily Pain (BP); General Health (GH); Vitality (VT); Social Functioning (SF); Mental Health (MH); and Role-Emotional (R-E). Scales are comprised of different numbers of items and use a variety of rating formats. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
Time Frame	100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	139	142	136	143
Physical Functioning	66.46 (24.47)	66.12 (23.95)	65.83 (23.34)	67.38 (24.30)
Role Physical	54.79 (30.21)	53.49 (30.72)	54.74 (29.33)	58.51 (26.98)
Bodily Pain	67.78 (24.74)	71.55 (25.17)	67.96 (26.18)	68.19 (24.15)
General Health	63.62 (19.93)	60.05 (19.86)	58.06 (20.25)	59.43 (19.38)
Vitality	54.91 (20.84)	58.13 (18.29)	54.42 (21.03)	53.56 (21.06)
Social Functioning	73.83 (25.89)	76.13 (26.52)	72.64 (26.96)	72.67 (26.68)
Role Emotional	81.73 (25.64)	80.44 (26.83)	86.68 (21.23)	81.83 (25.29)
Mental Health	76.68 (17.24)	80.17 (15.29)	77.85 (17.58)	76.75 (17.59)

2. Primary Outcome

Title	Functional Status
Description	To determine whether exercise or stress management improves self-reported physical and mental functioning compared to standard care at 100 days post hematopoietic cell transplantation (HCT) using evaluated patients. The Physical Component Score (PCS) and Mental Component Score (MCS) of the SF-36 will be the primary endpoint measures of functional status. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
Time Frame	100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	139	142	136	143
PCS	42.2 (10.47)	41.8 (9.59)	40.6 (10.49)	42.5 (9.22)
MCS	50.8 (10.44)	52.4 (9.43)	52.1 (9.70)	50.4 (10.69)

3. Secondary Outcome

Title	Cancer and Treatment Distress (CTXD)
Description	Cancer and treatment distress will be measured by the acute version of the Cancer and Treatment Distress (CTXD) scale, a 27 item validated measure of distress with domains of Uncertainty, Health Burden, Family Strain, Identity and Managing the Medical System used extensively in HCT studies. The scale ranges from 0 - 3, where a higher score reflects more distress.
Time Frame	100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	140	144	138	144
Mean (Standard Deviation) [units on a scale]	0.96 (0.56)	0.88 (0.60)	1.04 (0.66)	0.94 (0.57)

4. Secondary Outcome

Title	The Pittsburgh Sleep Quality Index (PSQI)
Description	The Pittsburgh Sleep Quality Index (PSQI) is a widely used seven item self-report measure of sleep patterns and difficulties. A modified version will be used to obtain self-reports of the following for the past week: sleep quality, sleep latency, sleep efficiency, and use of sleeping medications. The scale ranges from 0 - 21, where a higher score reflects worse sleep quality.
Time Frame	100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	132	136	135	138
Mean (Standard Deviation) [units on a scale]	4.55 (3.50)	3.49 (2.93)	4.44 (3.31)	4.02 (3.13)

5. Secondary Outcome

Title	Nausea
Description	Two questions using a similar format as the SF-36 were added to measure nausea. The scale ranges from 1 - 5, where a higher score indicates worse nausea.
Time Frame	100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	138	143	138	144
Mean (Standard Deviation) [units on a scale]	2.74 (1.38)	2.63 (1.41)	2.80 (1.47)	2.85 (1.49)

6. Secondary Outcome

Title	Days of Hospitalization
Description	The number of hospital days within the first 100 days after graft infusion will be collected for patients surviving at least 100 days.
Time Frame	100 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	175	172	172	173
Mean (Standard Deviation) [days]	21.1 (20.3)	22.7 (19.6)	21.6 (20.6)	20.9 (17.0)

7. Secondary Outcome

Title	SF-36 Late Outcomes
Description	The SF-36 PCS and MCS will be collected from participants at six months. Raw scores are converted to a standard metric (0-100), with higher scores being indicative of a better health state.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	125	122	117	128
PCS	44.5 (9.4)	42.3 (10.6)	43.4 (10.0)	42.8 (10.1)
MCS	51.6 (9.8)	52.5 (9.1)	50.7 (11.0)	51.7 (9.9)

8. Secondary Outcome

Title	Survival
Description	Both survival at 6 months and overall survival at last follow-up will be reported. Overall survival is defined as the interval between transplantation and death or last follow-up. Patients alive when the study closes or lost to follow up are censored at the date of last contact.
Time Frame	6 months and 1 year

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Exercise	Stress Management	Exercise and Stress Management	Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.	Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.	Exercise and Stress Management - Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.	Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
Measure Participants	180	178	178	175
6 months	89 49.4%	89 50%	86 48.3%	92 52.6%
1 year	85 47.2%	82 46.1%	72 40.4%	79 45.1%

Adverse Events

Time Frame	6-months post-transplant
Adverse Event Reporting Description	Serious adverse events are defined as events associated with death, life-threatening event, disability, congenital anomaly, required intervention to prevent permanent impairment or damage, hospitalization or other serious adverse event.
Arm/Group Title	Exercise		Stress Management		Exercise and Stress Management		Standard Care
Arm/Group Description	Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Exercise: Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.		Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient. Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.		Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient. Exercise and Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.		Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress). Standard Care: Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
All Cause Mortality
	Exercise		Stress Management		Exercise and Stress Management		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Exercise		Stress Management		Exercise and Stress Management		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/178 (0%)		0/175 (0%)		1/174 (0.6%)		0/174 (0%)
Psychiatric disorders
Depression	0/178 (0%)		0/175 (0%)		1/174 (0.6%)		0/174 (0%)
Other (Not Including Serious) Adverse Events
	Exercise		Stress Management		Exercise and Stress Management		Standard Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/178 (0%)		0/175 (0%)		0/174 (0%)		0/174 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.