Self-Management of Cancer-Related Fatigue by Adolescents
Study Details
Study Description
Brief Summary
This study will investigate self-management of cancer-related fatigue by adolescents through pilot study of an evidence based educational resource.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Cancer-related fatigue is a prevalent and distressing symptom which has a significant impact on quality of life for children and adolescents with cancer and their families. Evidence based guidelines issued by the Oncology Nursing Society and National Comprehensive Cancer Network recommend educational interventions for preventing and treating cancer-related fatigue.The primary study aim is to examine the relationships among: intensity of cancer-related fatigue; frequency of use of an evidence based educational resource for self-management of cancer-related fatigue; and perceived helpfulness of resource use. The secondary aim is to examine the relationship between the Fatigue Scale-Adolescent (FS-A) and the Symptom Distress Scale (SDS) 'tired' item as measures of intensity of cancer-related fatigue. The tertiary aim is to examine the feasibility of recruiting and retaining adolescents with cancer for longitudinal study of cancer-related fatigue.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Self-Management Arm Behavioral: 'Fatigue Facts & Fixes' |
Behavioral: 'Fatigue Facts & Fixes'
'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: "Why am I so tired?" (description of cancer-related fatigue); "What causes fatigue?" (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and "What can help me to not be so tired?" (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness. [baseline and weekly up to 8 weeks]
The FS-A is a 14-item self-report instrument which measures on a 5 point scale ranging from '1 - not at all' to '5 - all the time' the extent to which each of 14 statements describes how the respondent has been feeling during the past 7 days (Hinds et al., 2007). The potential score range is 14-70; higher scores represent greater fatigue (Hinds et al., 2007). The scores (1 through 5) on the Likert-type scales for resource use and resource helpfulness were determined at each post baseline time point, as were change from baseline values for the FS-A. All FS-A change from baseline values, per Resource Use or Resource Helpfulness Categorization, were combined regardless of post-baseline time point.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
adolescents 13-18 years inclusive
-
leukemia, lymphoma, or malignant solid tumor; newly diagnosed and within 2 weeks of initiating therapy
-
patient and consenting parent able to speak, read, and write English.
Exclusion Criteria:
- failure to meet all of inclusion criteria
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Seattle Children's Hospital | Seattle | Washington | United States | 98105 |
Sponsors and Collaborators
- Seattle Children's Hospital
- Alex's Lemonade Stand Foundation
Investigators
- Principal Investigator: Catherine Fiona Macpherson, PhD, Seattle Children's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SCH-12551
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | 'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: "Why am I so tired?" (description of cancer-related fatigue); "What causes fatigue?" (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and "What can help me to not be so tired?" (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource. |
| Period Title: Overall Study | |
| STARTED | 15 |
| COMPLETED | 15 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Group 1 |
|---|---|
| Arm/Group Description | 'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: "Why am I so tired?" (description of cancer-related fatigue); "What causes fatigue?" (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and "What can help me to not be so tired?" (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource. |
| Overall Participants | 15 |
| Age (Count of Participants) | |
| <=18 years |
15
100%
|
| Between 18 and 65 years |
0
0%
|
| >=65 years |
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
13.33
(3.18)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
7
46.7%
|
| Male |
8
53.3%
|
| Region of Enrollment (participants) [Number] | |
| United States |
15
100%
|
Outcome Measures
| Title | Change From Baseline in Fatigue Scale-Adolescent (FS-A) Score Categorized According to 1-5 Rating Scale of Resource Use and Resource Helpfulness. |
|---|---|
| Description | The FS-A is a 14-item self-report instrument which measures on a 5 point scale ranging from '1 - not at all' to '5 - all the time' the extent to which each of 14 statements describes how the respondent has been feeling during the past 7 days (Hinds et al., 2007). The potential score range is 14-70; higher scores represent greater fatigue (Hinds et al., 2007). The scores (1 through 5) on the Likert-type scales for resource use and resource helpfulness were determined at each post baseline time point, as were change from baseline values for the FS-A. All FS-A change from baseline values, per Resource Use or Resource Helpfulness Categorization, were combined regardless of post-baseline time point. |
| Time Frame | baseline and weekly up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Resource Use | Resource Helpfulness |
|---|---|---|
| Arm/Group Description | Fatigue Facts & Fixes was assessed for amount of resource use on a 1-5 Likert-type scale. | Fatigue Facts & Fixes was assessed for amount of resource helpfulness on a 1-5 Likert-type scale. |
| Measure Participants | 15 | 15 |
| 1 - not at all |
-3
|
-3
|
| 2 - |
-4
|
-4
|
| 3- |
-4
|
-7
|
| 4 - |
-8.5
|
-2.5
|
| 5 - a lot |
-1
|
-4
|
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Group 1 | |
| Arm/Group Description | 'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: "Why am I so tired?" (description of cancer-related fatigue); "What causes fatigue?" (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and "What can help me to not be so tired?" (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource. | |
All Cause Mortality |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Group 1 | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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.
Results Point of Contact
| Name/Title | Catherine Fiona Macpherson, PhD |
|---|---|
| Organization | Seattle Children's Hospital |
| Phone | 206-987-2032 |
| catherine.macpherson@seattlechildrens.org |
- SCH-12551