NeoplasmsNCT02459769
Exercise Intervention for LGBT Cancer Survivors
A study testing Exercise for Cancer Patients in people with Neoplasms, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to test preliminary efficacy, as well as acceptability and feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer survivors and their non-professional caregivers as dyads to either an individual or a dyadic Exercise for Cancer Patients (EXCAP)… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neoplasms
- What is being tested?
- Exercise for Cancer Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2015to 22 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (Survivors): To be included in the study, cancer survivors must:
- Have had a diagnosis of cancer (any cancer type excluding squamous and basal cell [skin cancers]) and have completed primary surgery, chemotherapy, and/or radiation (those on continued adjuvant treatment are still eligible),
- Identify as lesbian, gay, bisexual, or transgender, or have a same-sex romantic partner,
- Have a caregiver willing to participate in the study (defined as anyone who provided emotional support or tangible assistance during the survivors' cancer experience),
- Be able to read English,
- Be 21 years of age or older, and
Show all 12Show fewer
- Give written informed consent.
- (Caregivers): Caregivers must:
- Be nominated by a cancer survivor,
- Be able to read English,
- Be 21 years of age or older,
- Give written informed consent.
Who cannot join
- Have physical limitations (e.g., cardiorespiratory, orthopedic) contraindicating participating in a low- to moderate-intensity home-based walking and progressive resistance program and physical function testing, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor (or any of these three physicians' designees),
- For caregivers, be currently undergoing active treatment for cancer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exercise Intervention for Lesbian, Gay, Bisexual, and Transgender (LGBT) Cancer Survivors and Caregivers
The purpose of this study is to test preliminary efficacy, as well as acceptability and feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer survivors and their non-professional caregivers as dyads to either an individual or a dyadic Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be psychological distress. Analyses will involve pre-post comparisons of outcomes across the study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will result in greater improvements in psychological distress than an individual intervention.
Read the detailed description
The proposed randomized controlled trial aims to recruit 70 lesbian, gay, bisexual, and transgender (LGBT) cancer survivors who have completed treatment (surgery, radiation, or chemotherapy) within the past 24 months, so as to have a final, evaluable sample of 60 LGBT survivors after attrition. The proposed RCT will also recruit caregivers (broadly defined) of the above cancer survivors. Each recruited cancer survivor will be asked to name a person who they feel provided care (emotional, informational, tangible, etc.) during their cancer experience, with no further strictures placed on this relationship in terms of type or duration. The caregiver will be approached to participate in the RCT. Thus the sample will consist of 70 LGBT survivors (60 evaluable) and their caregivers (140 individuals total/120 evaluable). Recruitment and primary analyses will specifically target the LGBT cancer survivor.
All data will be gathered from participants 21 years of age or older. Participants are cancer survivors who have completed treatments or caregivers of cancer survivors; both survivors and caregivers are able to read and understand English.
- Conditions
- Neoplasms
- Being tested
- Exercise for Cancer Patients
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise for Cancer PatientsBehavioural
Also called EXCAP
a standardized, daily, 6 week, home-based, progressive exercise program
| Study group | Role | What they receive |
|---|---|---|
| Dyadic Exercise Intervention | Active comparator | Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. Receives: Behavioral: Exercise for Cancer Patients |
| Individual Exercise Intervention | Other | Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. Receives: Behavioral: Exercise for Cancer Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Psychological Distress
Self-reported psychological distress was measured with the Profile of Mood States (POMS) total score among LGBT cancer survivors. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress.
Measured: Assessed at 8 weeks
Secondary outcomes (5)
Biological Endpoints: Cortisol
The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: serum cortisol among LGBT cancer survivors.
Measured: Assessed at 8 weeks
Biological Endpoints: Serum Amyloid A
The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of early inflammation serum amyloid A (SAA) among LGBT cancer survivors.
Measured: Assessed at 8 weeks
Biological Endpoints: C-reactive Protein
The secondary aim is to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on biological endpoints associated with distress: markers of C-reactive protein (CRP) among LGBT cancer survivors.
Measured: Assessed at 8 weeks
Mechanistic Outcomes: Support
Social support from the care partner was measured with the Dyadic Support Questionnaire (DSQ) among LGBT cancer survivors. The DSQ is an 18-item survey based on four functions of social support (emotional, appraisal, instrumental, and informational support). Nine items measure received social support, that is, support provided by the partner. Items are anchored using a Likert scale ranging from 1 to 5 (from not at all to a great deal). Items were summed to create a scale for received support ranging from 9-45, with higher scores indicating more support.
Measured: Assessed at 8 weeks
Mechanistic Outcomes: Adherence
We also aim to determine the preliminary effect of EXCAP-PA versus survivor-only EXCAP©® on social support from the care partners intervention adherence (actigraphy) among LGBT cancer survivors. The actigraph features a variable epoch length which can be set between 1 to 240 seconds. Software supplied by the manufacturer was used to determine number of minutes of moderate or higher activity during each assessment period.
Measured: Assessed at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start15 Aug 2015
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles Kamen, University of Rochester
- Investigators
- Charles Kamen, PhD, MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459769
- Sponsor's protocol ID
- 56965
- Status last verified
- Feb 2023
- First submitted
- 21 May 2015
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise Intervention for Lesbian, Gay, Bisexual, and Transgender (LGBT) Cancer Survivors and Caregivers
- ClinicalTrials.gov ID
- NCT02459769
- Acronym / sponsor ID
- 56965
- Conditions
- Neoplasms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 15 Aug 2015 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test preliminary efficacy, as well as acceptability and feasibility, of a dyadic exercise intervention, the current study will randomize LGBT cancer survivors and their non-professional caregivers as dyads to either an individual or a dyadic Exercise for Cancer Patients (EXCAP) intervention. The primary outcome assessed will be psychological distress. Analyses will involve pre-post comparisons of outcomes across the study arms, testing the hypothesis that a 6 week, daily, dyadic exercise intervention will result in greater improvements in psychological distress than an individual intervention.
Detailed description
The proposed randomized controlled trial aims to recruit 70 lesbian, gay, bisexual, and transgender (LGBT) cancer survivors who have completed treatment (surgery, radiation, or chemotherapy) within the past 24 months, so as to have a final, evaluable sample of 60 LGBT survivors after attrition. The proposed RCT will also recruit caregivers (broadly defined) of the above cancer survivors. Each recruited cancer survivor will be asked to name a person who they feel provided care (emotional, informational, tangible, etc.) during their cancer experience, with no further strictures placed on this relationship in terms of type or duration. The caregiver will be approached to participate in the RCT. Thus the sample will consist of 70 LGBT survivors (60 evaluable) and their caregivers (140 individuals total/120 evaluable). Recruitment and primary analyses will specifically target the LGBT cancer survivor.
All data will be gathered from participants 21 years of age or older. Participants are cancer survivors who have completed treatments or caregivers of cancer survivors; both survivors and caregivers are able to read and understand English.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic Exercise Intervention | Active comparator | Behavioral: Exercise for Cancer PatientsProgressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and 3 times/week resistance prescription for 6 weeks). Cancer survivor and caregiver are also asked to discuss ways they can support one another in a) remaining adherent to exercise, and b) dealing with stress, including LGBT-specific minority stress. |
| Individual Exercise Intervention | Other | Behavioral: Exercise for Cancer PatientsProgressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and 3 times/week resistance prescription for 6 weeks). The caregiver is told not to change his/her exercise behavior in any way. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- (Survivors): To be included in the study, cancer survivors must:
- Have had a diagnosis of cancer (any cancer type excluding squamous and basal cell [skin cancers]) and have completed primary surgery, chemotherapy, and/or radiation (those on continued adjuvant treatment are still eligible),
- Identify as lesbian, gay, bisexual, or transgender, or have a same-sex romantic partner,
- Have a caregiver willing to participate in the study (defined as anyone who provided emotional support or tangible assistance during the survivors' cancer experience),
- Be able to read English,
Key exclusion criteria (2 listed)
- Have physical limitations (e.g., cardiorespiratory, orthopedic) contraindicating participating in a low- to moderate-intensity home-based walking and progressive resistance program and physical function testing, as assessed by their medical oncologist, their primary care physician, and/or the study medical monitor (or any of these three physicians' designees),
- For caregivers, be currently undergoing active treatment for cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise for Cancer PatientsAlso: EXCAPa standardized, daily, 6 week, home-based, progressive exercise program | Behavioural | Dyadic Exercise Intervention, Individual Exercise Intervention |
Primary outcome
Self-Reported Psychological Distress
Time frame: Assessed at 8 weeks
Self-reported psychological distress was measured with the Profile of Mood States (POMS) total score among LGBT cancer survivors. The POMS consists of 30 adjectives that subjects rate on a five-point scale with "1" = "Not at all" and "5" = "Extremely" to describe their moods over the past week. The total score can be calculated by adding the raw scores from tension, depression, anger, fatigue and confusion-focused items and then subtracting the vigour-focused items. This will give a value between -24 and 177, with higher scores indicating higher psychological distress.
5 secondary outcomes
Biological Endpoints: Cortisol
Time frame: Assessed at 8 weeks
Biological Endpoints: Serum Amyloid A
Time frame: Assessed at 8 weeks
Biological Endpoints: C-reactive Protein
Time frame: Assessed at 8 weeks
Mechanistic Outcomes: Support
Time frame: Assessed at 8 weeks
Mechanistic Outcomes: Adherence
Time frame: Assessed at 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles Kamen, PhD, MPH principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise for Cancer Patients in people with Neoplasms, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Psychological Distress (time frame: Assessed at 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.