Exercise Intervention for Cancer Survivors and Caregivers

• Sponsor: University of Rochester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01883635
• Collaborator: (none)
• Enrollment: 44
• Location: 1
• Arms: 2
• Duration (Months): 27
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

The purpose of the study is to see whether exercise can improve the health and well-being of cancer survivors. We also want to know about the health and well being of caregivers.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Behavioral: Survivor-only progressive walking and resistance exercise; Behavioral: Dyadic progressive walking and resistance exercise	Phase 1

Detailed Description

This was a pilot feasibility study to refine our methodology before a larger Phase II trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Dyadic Exercise Intervention for Cancer Survivors and Caregivers
• Study Start Date: May 1, 2013
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Individual Exercise Intervention Survivor-only progressive walking and resistance exercise	Behavioral: Survivor-only progressive walking and resistance exercise; Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only; Other Names: EXCAP
Experimental: Dyadic Exercise Intervention Dyadic progressive walking and resistance exercise	Behavioral: Dyadic progressive walking and resistance exercise; Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad; Other Names: EXCAP-PA

Outcome Measures

Primary Outcome Measures

1. Psychological Distress [Baseline to post-intervention (6 weeks later)]

   Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.

Secondary Outcome Measures

1. Immune Biomarkers [Baseline to post-intervention (6 weeks later)]

   We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.

Other Outcome Measures

1. Provision of Social Support [Baseline to post-intervention (6 weeks later)]

   Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria for Cancer Survivors:

• Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin cancers) and have received surgery, chemotherapy, and/or radiation therapy within the last 1-12 months.

• Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or physicians designee) following cancer treatments

• Have a caregiver willing to participate int he study

• Be able to read English

• Be 21 years of age or older

• Give written informed consent

Inclusion Criteria for Caregivers:

• Be nominated by a cancer survivor

• Be able to read English

• Be 21 years of age or older

• Give written informed consent

Exclusion Criteria:

• have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating participation in a low to moderate intensity home based walking and progressive resistance program, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor.

• For caregivers, be currently undergoing active treatment for cancer

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Charles Kamen, PhD, University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Charles Kamen, Assistant Research Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT01883635
• Other Study ID Numbers: 46413
• First Posted: Jun 21, 2013
• Last Update Posted: Feb 5, 2016
• Last Verified: Jan 1, 2016

Study Results

Participant Flow

Recruitment Details	Both cancer survivors and their caregivers were screened, consented, and randomized to one of two intervention arms (Individual Exercise or Dyadic Exercise). 22 cancer survivor/caregiver dyads were recruited (44 individuals).

Arm/Group Title	Individual Exercise Intervention	Dyadic Exercise Intervention
Arm/Group Description	Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program	Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program
Period Title: Overall Study
STARTED	24	20
COMPLETED	20	20
NOT COMPLETED	4	0

Baseline Characteristics

Arm/Group Title	Individual Exercise Intervention	Dyadic Exercise Intervention	Total
Arm/Group Description	Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program	Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program	Total of all reporting groups
Overall Participants	24	20	44
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	19 79.2%	16 80%	35 79.5%
>=65 years	5 20.8%	4 20%	9 20.5%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	56.17 (11.05)	53.90 (12.59)	55.12 (11.71)
Sex: Female, Male (Count of Participants)
Female	12 50%	12 60%	24 54.5%
Male	12 50%	8 40%	20 45.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 5%	1 2.3%
Not Hispanic or Latino	24 100%	19 95%	43 97.7%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	24 100%	20 100%	44 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	24 100%	20 100%	44 100%

Outcome Measures

1. Primary Outcome

Title	Psychological Distress
Description	Change in psychological distress in the cancer survivor from baseline to 6 weeks, as measured by the Profile of Moods States (POMS) total score. At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-200, with lower scores signifying less distress. We subtracted the baseline POMS score from the 6 week POMS score; the change score reported below thus has a range from -200 to 200, with lower scores signifying less distress.
Time Frame	Baseline to post-intervention (6 weeks later)

Outcome Measure Data

Analysis Population Description

The Primary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).

Arm/Group Title	Individual Exercise Intervention	Dyadic Exercise Intervention
Arm/Group Description	Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program	Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program
Measure Participants	22	20
Mean (Standard Deviation) [units on a scale]	2.25 (14.24)	-.65 (9.84)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Individual Exercise Intervention, Dyadic Exercise Intervention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.14
	Comments
	Method	t-test, 2 sided
	Comments	degrees of freedom=40

2. Secondary Outcome

Title	Immune Biomarkers
Description	We measured improvement in immune biomarkers with IL-6, an inflammatory cytokine assessed in the serum of cancer survivors. Numbers presented below are change scores calculated by subtracting baseline IL-6 from post-intervention IL-6 (6 weeks later); lower numbers indicate less inflammation, hypothesized to be linked with better immune function.
Time Frame	Baseline to post-intervention (6 weeks later)

Outcome Measure Data

Analysis Population Description

The Secondary Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).

Arm/Group Title	Individual Exercise Intervention	Dyadic Exercise Intervention
Arm/Group Description	Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program	Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program
Measure Participants	22	20
Mean (Standard Deviation) [ng/mL]	1.17 (1.57)	1.42 (1.24)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Individual Exercise Intervention, Dyadic Exercise Intervention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.65
	Comments
	Method	t-test, 2 sided
	Comments	degrees of freedom=40

3. Other Pre-specified Outcome

Title	Provision of Social Support
Description	Change in provision of social support from baseline to 6 weeks as reported by the cancer survivor was measured by the Dyadic Support Questionnaire (DSQ). At each time point (baseline and 6 weeks), this questionnaire had a total score range of 0-45, with higher scores signifying more support. We subtracted the baseline score from the 6 week DSQ score; the change score reported below thus has a range from -45 to 45, with higher scores signifying more support.
Time Frame	Baseline to post-intervention (6 weeks later)

Outcome Measure Data

Analysis Population Description

This Additional Outcome analysis looked only at cancer survivors assigned to the Individual Exercise Intervention (n=22) and the Dyadic Exercise Intervention (n=20).

Arm/Group Title	Individual Exercise Intervention	Dyadic Exercise Intervention
Arm/Group Description	Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program	Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks) Progressive walking and resistance exercise program
Measure Participants	22	20
Mean (Standard Deviation) [units on a scale]	-2.90 (1.03)	-1.90 (1.10)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Individual Exercise Intervention, Dyadic Exercise Intervention
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.51
	Comments
	Method	t-test, 2 sided
	Comments	degrees of freedom=40

Adverse Events

Time Frame	2 years, 3 months
Arm/Group Title	Individual Exercise Intervention - Cancer Survivors		Dyadic Exercise Intervention - Cancer Survivors		Individual Exercise Intervention - Caregivers		Dyadic Exercise Intervention - Caregivers
Arm/Group Description	Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)		Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)		Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)		Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
All Cause Mortality
	Individual Exercise Intervention - Cancer Survivors		Dyadic Exercise Intervention - Cancer Survivors		Individual Exercise Intervention - Caregivers		Dyadic Exercise Intervention - Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Individual Exercise Intervention - Cancer Survivors		Dyadic Exercise Intervention - Cancer Survivors		Individual Exercise Intervention - Caregivers		Dyadic Exercise Intervention - Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		0/20 (0%)		0/22 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Individual Exercise Intervention - Cancer Survivors		Dyadic Exercise Intervention - Cancer Survivors		Individual Exercise Intervention - Caregivers		Dyadic Exercise Intervention - Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/22 (0%)		1/20 (5%)		0/22 (0%)		1/20 (5%)
Cardiac disorders
1 mm segment depression in EKG	0/22 (0%)	0	0/20 (0%)	0	0/22 (0%)	0	1/20 (5%)	1
Musculoskeletal and connective tissue disorders
Back Pain	0/22 (0%)	0	1/20 (5%)	1	0/22 (0%)	0	0/20 (0%)	0

Limitations/Caveats

First, this was a pilot, Phase I trial, and hence had a limited sample size. This study was conducted in a single geographic region. Finally, we analyzed only two time points: baseline and post-intervention.

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.