Domestic PartnershipNCT03418025
Exercising Together During Radiation Treatment
A study testing Exercise Intervention, Questionnaire Administration and Survey Administration in people with Domestic Partnership and Prostate Carcinoma, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
This pilot clinical trial studies how well the Exercising Together program works in helping couples cope with radiation treatment for prostate cancer. Treatments for cancer can cause side effects for the patient, such as fatigue, add stress for the spousal caregiver, and put strain on the marital relationship. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Domestic Partnership, Prostate Carcinoma, Spouse
- What is being tested?
- Exercise Intervention, Questionnaire Administration and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 23 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- PATIENTS
- Histologically confirmed prostate cancer (confirmed by self-report on Health History Questionnaire)
- Scheduled to receive a course (5-8 weeks) of radiation treatment for prostate cancer at Oregon Health \& Science University (OHSU) Department of Radiation Medicine (confirmed by self-report on Health History Questionnaire)
- Currently residing with an identifiable spouse (or co-residing partner) willing to participate (confirmed by self-report on Health History Questionnaire)
- SPOUSES
- Currently residing with the prostate cancer patient (confirmed by self-report on Health History Questionnaire)
Who cannot join
- Cognitive difficulties that preclude answering the survey questions or giving informed consent
- Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise (for patient: confirmed by email and/or Electronic Privacy Information Center [EPIC] by Dr. Hung; for spouse: must answer 'No' to exercise pre-participation screening questions (question #20 \& #21) in Health History Questionnaire (HHQ); if spouse answers 'Yes' to either question they will be considered eligible upon physician clearance; the exercise pre-participation screening questions are based on the American College of Sports Medicine 2016 Exercise pre-participation screening criteria)
- Currently participating in partnered strength training 2 or more times per week (confirmed by self-report on the Godin Leisure Time Exercise Questionnaire)
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Exercising Together: An Intervention for Couples Coping With Prostate Cancer During Radiation Treatment
This pilot clinical trial studies how well the Exercising Together program works in helping couples cope with radiation treatment for prostate cancer. Treatments for cancer can cause side effects for the patient, such as fatigue, add stress for the spousal caregiver, and put strain on the marital relationship. The Exercising Together program is designed to promote teamwork and emotional intimacy during exercise, which itself can help manage fatigue and stress for the patient and spouse, and may facilitate communication between partners about day-to-day energy, abilities, and motivation.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility and acceptability of offering the Exercising Together program to couples during the time when men are undergoing an 8 week radiation treatment regimen.
SECONDARY OBJECTIVES:
- Examine the efficacy of partnered strength training on objective physical function, self-report function, symptoms and intimacy in both the patient and his spouse.
OUTLINE:
All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment.
EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a digital video disc (DVD) of a partnered strength training exercise program to continue on their own after radiation is completed.
After completion of the supervised exercise program, participants are followed up at 8 weeks.
- Conditions
- Domestic Partnership, Prostate Carcinoma, Spouse
- Being tested
- Exercise Intervention, Questionnaire Administration, Survey Administration
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise InterventionBehavioural
Undergo Exercise Together intervention
Questionnaire AdministrationOther
Ancillary studies
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (Exercising Together program) | Experimental | Exercise Intervention. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment.
EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a DVD of a partnered strength training exercise program to continue on their own after radiation is completed. Receives: Behavioral: Exercise Intervention; Other: Questionnaire Administration; Other: Survey Administration |
| Group II (pre and post testing) | Active comparator | Questionnaire Administration \& Survey Administration. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment. Receives: Other: Questionnaire Administration; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Will be determined as the number of couples who enroll out of those approached and the number of couples who opt to participate in Exercising Together versus to participate as controls. Will evaluate using descriptive statistics.
Measured: Up to 8 weeks post radiation treatment
Physical function
Will be measured by the Physical Performance Battery (PPB), developed for the Established Populations for Epidemiologic Studies of the Elderly study. The PPB consists of three timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4, based on quartiles of performance, then scores are summed. Higher scores indicate better physical function.
Measured: Up to 8 weeks post-radiation treatment
400m walk Test
The 400m walk test is a self-paced, submaximal exercise test. Participants will be required to move as fast as they can along a 20m course, demarked by two cones, until they have completed 10 laps of the course (400m). The time taken to complete the test will be recorded.
Measured: Up to 8 weeks post-radiation treatment
Acceptability
Will be measured by the average attendance at classes over the course of his radiation therapy. This will be calculated as the total number of classes attended divided by the total possible they could attend over the course of radiation therapy. Attendance will be categorized by sessions couples attended together and those where only one partner attends. Will evaluate using descriptive statistics.
Measured: Up to 8 weeks post-radiation treatment
Depressive symptoms
Will be measured with the Center for Epidemiological Studies-Depression (CES-D) scale. Scores range from 0-60, with higher scores indicating > depressive symptomology.
Measured: Up to 8 weeks post-radiation treatment
Anxiety
Will be measured from the Symptom Checklist - 90 Anxiety Scale (SCL-90 ANX) which includes 10 items representing anxiety symptoms, scored on a 5 point scale ranging from 0 (not at all) to 4 (extremely).
Measured: Up to 8 weeks post-radiation treatment
Physical intimacy
Physical intimacy behavior of patient and spouse will be measured using the Physical intimacy behavior scale. Respondents are asked to report the frequency with which they engage in, initiate and avoid each of four affectionate and two sexual behaviors. Three scales assess the frequency, initiation and avoidance of affectionate and sexual behaviors.
Measured: Up to 8 weeks post-radiation treatment
Strain
Spouse strain will be measured with the role overload scale, which assesses the extent a spouse's time and energy are exhausted by demands of care for their partner.
Measured: Up to 8 weeks post-radiation treatment
Dyadic coping
Two types of dyadic coping will be measured. Active engagement assesses the extent to which the survivor (SVR) and spouse view their partner's active involvement and joint problem-solving. Participants respond to five items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived active engagement. Protective buffering assesses the extent to which the SVR and spouse view their partner's use of hiding concerns and denying worries. Participants respond to six items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived protective buffering.
Measured: Up to 8 weeks post-radiation treatment
Exercise outside the exercise intervention
Will measure outside activity with the Modified Godin Leisure-Time Exercise Questionnaire (GLTEQ). This survey, reported in average minutes per week over the past month, will be broken down into four categories: mild effort (minimal effort), moderate exercise (not exhausting), and strenuous exercise (heart beats rapidly), as well as resistance (weight bearing exercise). The questionnaire will be scored three different ways, to better capture different aspects of PA: 1) total activity = vigorous + moderate + mild + resistance 2) physical activity guidelines = moderate + (vigorous x 2) 3) moderate + vigorous.
Measured: Up to 8 weeks post-radiation treatment
Subjective evaluation of Exercising Together Program
For couples who opt to participate in Exercising Together will also ask them to fill out a survey asking about their experience in the program. They will be asked to rate their overall experience in the exercise classes using a 1 to 10 likert scale with 1 being poor and 10 being exceptional as well as indicate how much they agree or disagree with perceptions of the class.
Measured: Up to 8 weeks post-radiation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Nov 2017
- Primary completion18 May 2018
- Study completion23 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Domestic PartnershipStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Health and Science University
- Responsible party
- Principal investigator, Kerri Winters, OHSU Knight Cancer Institute
- Investigators
- Kerri Winters-Stone, Principal investigator, OHSU Knight Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418025
- Sponsor's protocol ID
- STUDY00017367
- Other IDs
- NCI-2018-00031, CPC-17135-L, IRB00017367
- Status last verified
- Oct 2020
- First submitted
- 24 Jan 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Winters-Stone KM, Lyons KS, Beer TM, Skiba MB, Hung A. A pilot feasibility study of Exercising Together(c) during radiation therapy for prostate cancer: a dyadic approach for patients and spouses. Pilot Feasibility Stud. 2021 Dec 8;7(1):216. doi: 10.1186/s40814-021-00952-7.
PubMed 34879873
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercising Together: An Intervention for Couples Coping With Prostate Cancer During Radiation Treatment
- ClinicalTrials.gov ID
- NCT03418025
- Acronym / sponsor ID
- STUDY00017367
- Conditions
- Domestic Partnership, Prostate Carcinoma, Spouse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- Oregon Health and Science University
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 18 May 2018 (actual)
- Study completion
- 23 Oct 2018 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot clinical trial studies how well the Exercising Together program works in helping couples cope with radiation treatment for prostate cancer. Treatments for cancer can cause side effects for the patient, such as fatigue, add stress for the spousal caregiver, and put strain on the marital relationship. The Exercising Together program is designed to promote teamwork and emotional intimacy during exercise, which itself can help manage fatigue and stress for the patient and spouse, and may facilitate communication between partners about day-to-day energy, abilities, and motivation.
Detailed description
PRIMARY OBJECTIVE:
- Determine the feasibility and acceptability of offering the Exercising Together program to couples during the time when men are undergoing an 8 week radiation treatment regimen.
SECONDARY OBJECTIVES:
- Examine the efficacy of partnered strength training on objective physical function, self-report function, symptoms and intimacy in both the patient and his spouse.
OUTLINE:
All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment.
EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a digital video disc (DVD) of a partnered strength training exercise program to continue on their own after radiation is completed.
After completion of the supervised exercise program, participants are followed up at 8 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (Exercising Together program) | Experimental | Behavioral: Exercise Intervention, Other: Questionnaire Administration, Other: Survey AdministrationExercise Intervention. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment. EXERCISING TOGETHER PROGRAM: Participants complete three exercise sessions (approximately 1 hour per session) per week over 5-8 weeks during radiation treatment. Participants also receive a DVD of a partnered strength training exercise program to continue on their own after radiation is completed. |
| Group II (pre and post testing) | Active comparator | Other: Questionnaire Administration, Other: Survey AdministrationQuestionnaire Administration \& Survey Administration. All participants complete questionnaires about their health status, physical activity habits and relationship with their spouse/partner and undergo four physical tests at baseline and at the end of the 5-8 week radiation treatment. The questionnaires are then completed one final time 8 weeks following the completion of radiation treatment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- PATIENTS
- Histologically confirmed prostate cancer (confirmed by self-report on Health History Questionnaire)
- Scheduled to receive a course (5-8 weeks) of radiation treatment for prostate cancer at Oregon Health \& Science University (OHSU) Department of Radiation Medicine (confirmed by self-report on Health History Questionnaire)
- Currently residing with an identifiable spouse (or co-residing partner) willing to participate (confirmed by self-report on Health History Questionnaire)
- SPOUSES
Key exclusion criteria (3 listed)
- Cognitive difficulties that preclude answering the survey questions or giving informed consent
- Medical condition, movement or neurological disorder, or medication that contraindicates participation in resistance exercise (for patient: confirmed by email and/or Electronic Privacy Information Center [EPIC] by Dr. Hung; for spouse: must answer 'No' to exercise pre-participation screening questions (question #20 \& #21) in Health History Questionnaire (HHQ); if spouse answers 'Yes' to either question they will be considered eligible upon physician clearance; the exercise pre-participation screening questions are based on the American College of Sports Medicine 2016 Exercise pre-participation screening criteria)
- Currently participating in partnered strength training 2 or more times per week (confirmed by self-report on the Godin Leisure Time Exercise Questionnaire)
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 InterventionUndergo Exercise Together intervention | Behavioural | Group I (Exercising Together program) |
| Questionnaire AdministrationAncillary studies | Other | Group I (Exercising Together program), Group II (pre and post testing) |
| Survey AdministrationAncillary studies | Other | Group I (Exercising Together program), Group II (pre and post testing) |
Primary outcome
Feasibility
Time frame: Up to 8 weeks post radiation treatment
Will be determined as the number of couples who enroll out of those approached and the number of couples who opt to participate in Exercising Together versus to participate as controls. Will evaluate using descriptive statistics.
Physical function
Time frame: Up to 8 weeks post-radiation treatment
Will be measured by the Physical Performance Battery (PPB), developed for the Established Populations for Epidemiologic Studies of the Elderly study. The PPB consists of three timed tests: 5 repeated chair stands, standing balance, and gait speed over 4 meters. Each test is scored 0 (unable) to 4, based on quartiles of performance, then scores are summed. Higher scores indicate better physical function.
400m walk Test
Time frame: Up to 8 weeks post-radiation treatment
The 400m walk test is a self-paced, submaximal exercise test. Participants will be required to move as fast as they can along a 20m course, demarked by two cones, until they have completed 10 laps of the course (400m). The time taken to complete the test will be recorded.
Acceptability
Time frame: Up to 8 weeks post-radiation treatment
Will be measured by the average attendance at classes over the course of his radiation therapy. This will be calculated as the total number of classes attended divided by the total possible they could attend over the course of radiation therapy. Attendance will be categorized by sessions couples attended together and those where only one partner attends. Will evaluate using descriptive statistics.
Depressive symptoms
Time frame: Up to 8 weeks post-radiation treatment
Will be measured with the Center for Epidemiological Studies-Depression (CES-D) scale. Scores range from 0-60, with higher scores indicating > depressive symptomology.
Anxiety
Time frame: Up to 8 weeks post-radiation treatment
Will be measured from the Symptom Checklist - 90 Anxiety Scale (SCL-90 ANX) which includes 10 items representing anxiety symptoms, scored on a 5 point scale ranging from 0 (not at all) to 4 (extremely).
Physical intimacy
Time frame: Up to 8 weeks post-radiation treatment
Physical intimacy behavior of patient and spouse will be measured using the Physical intimacy behavior scale. Respondents are asked to report the frequency with which they engage in, initiate and avoid each of four affectionate and two sexual behaviors. Three scales assess the frequency, initiation and avoidance of affectionate and sexual behaviors.
Strain
Time frame: Up to 8 weeks post-radiation treatment
Spouse strain will be measured with the role overload scale, which assesses the extent a spouse's time and energy are exhausted by demands of care for their partner.
Dyadic coping
Time frame: Up to 8 weeks post-radiation treatment
Two types of dyadic coping will be measured. Active engagement assesses the extent to which the survivor (SVR) and spouse view their partner's active involvement and joint problem-solving. Participants respond to five items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived active engagement. Protective buffering assesses the extent to which the SVR and spouse view their partner's use of hiding concerns and denying worries. Participants respond to six items using a Likert scale from 1 (never) to 5 (very often). Higher scores indicate higher levels of perceived protective buffering.
Exercise outside the exercise intervention
Time frame: Up to 8 weeks post-radiation treatment
Will measure outside activity with the Modified Godin Leisure-Time Exercise Questionnaire (GLTEQ). This survey, reported in average minutes per week over the past month, will be broken down into four categories: mild effort (minimal effort), moderate exercise (not exhausting), and strenuous exercise (heart beats rapidly), as well as resistance (weight bearing exercise). The questionnaire will be scored three different ways, to better capture different aspects of PA: 1) total activity = vigorous + moderate + mild + resistance 2) physical activity guidelines = moderate + (vigorous x 2) 3) moderate + vigorous.
Subjective evaluation of Exercising Together Program
Time frame: Up to 8 weeks post-radiation treatment
For couples who opt to participate in Exercising Together will also ask them to fill out a survey asking about their experience in the program. They will be asked to rate their overall experience in the exercise classes using a 1 to 10 likert scale with 1 being poor and 10 being exceptional as well as indicate how much they agree or disagree with perceptions of the class.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Derived from this study: PubMed 34879873Winters-Stone KM, Lyons KS, Beer TM, Skiba MB, Hung A. A pilot feasibility study of Exercising Together(c) during radiation therapy for prostate cancer: a dyadic approach for patients and spouses. Pilot Feasibility Stud. 2021 Dec 8;7(1):216. doi: 10.1186/s40814-021-00952-7.
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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.
Kerri Winters-Stone principal investigator
OHSU Knight Cancer Institute
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 Intervention, Questionnaire Administration and Survey Administration in people with Domestic Partnership and Prostate Carcinoma, run by OHSU Knight Cancer Institute 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 6 inclusion and 3 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 8 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility (time frame: Up to 8 weeks post radiation treatment). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03418025, which also lists 1 linked publication.
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 8 Oct 2020.