AzTrials
AzTrials

Physical ActivityNCT03266718

Move 2 Health: A Couple-Based Physical Activity Intervention for Cancer Survivors

A study testing Physical Activity Intervention in people with Physical Activity and Cancer Survivor, run by Duke University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This pilot study will develop and test a couple-based physical activity intervention among cancer survivors and their partners. Aim 1: To determine the feasibility and acceptability of a couple-based physical activity intervention for cancer survivors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Physical Activity, Cancer Survivor
What is being tested?
Physical Activity Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
1 Jul 2015to 11 Dec 2016
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Survivor participants are those who have been diagnosed with breast or prostate cancer, who are married or in a committed relationship and live with their partner, and who are sedentary (e.g., not undertaking dedicated physical activity on 3 or more days per week). Both survivors and their partners must be at least 18 years of age, be fluent in English, and be eligible and willing to participate.

Who cannot join

  • We will exclude patients and/or partners with known metastatic disease, who are hearing impaired, who are deemed too sick to participate, who have a medical condition that prohibits them from prolonged walking, who are participating in another research study that promotes increased exercise, or who have evidence of unstable cognitive or mental health problems who cannot properly provide consent.

About this study

Official title: A Couple-Based Physical Activity Intervention for Cancer Survivors

This pilot study will develop and test a couple-based physical activity intervention among cancer survivors and their partners.

Aim 1: To determine the feasibility and acceptability of a couple-based physical activity intervention for cancer survivors. Feasibility will be quantified using rates of study eligibility, overall accrual, attrition, and adherence to the study protocol. Acceptability will be assessed via couples' ratings on a standardized measure of treatment effectiveness/ satisfaction, supplemented open-ended questions

Read more

Aim 2: To provide preliminary data on the effects of a couple-based physical activity intervention relative to a wait list control group on survivor outcomes (i.e., level of physical activity, quality of life, self-efficacy for achieving and maintaining physical activity goals, perceived partner support for physical activity, and quality of the survivor-partner relationship). The investigators hypothesize that the intervention will produce benefits in each of these domains.

Aim 3: To provide preliminary data on the effects of a couple-based physical activity intervention relative to a wait list control group on partner outcomes (i.e., partner's level of physical activity, self-efficacy for helping the survivor achieve and maintain physical activity goals, and quality of the survivor-partner relationship). The investigators hypothesize that the couple-based intervention will produce benefits in each of these domains.

Read the detailed description

Background and Significance:

Physical activity (PA) is an essential part of cancer survivors' treatment plan as it helps prevent recurrence and improves cardiovascular fitness and downstream cardiovascular risk, the cause for most deaths in cancer survivors. Additional benefits of increasing PA include improvements in body composition, physical function, psychological outcomes, and quality of life. However, most survivors are not sufficiently active and would benefit from an intervention to promote PA. Prior PA interventions for cancer survivors have had mixed success. A recent systematic review identified 14 RCTs testing exercise interventions among sedentary cancer survivors and concluded that there was insufficient evidence that existing interventions are successful in achieving recommended levels of PA. In particular, there has been a lack of attention to psychosocial aspects of changing behavior, and to strategies that promote independent exercise behavior that can be maintained over time. Thus, it is clear that novel approaches to PA interventions are needed.

Design:

This is a two-arm randomized controlled trial to evaluate a couple-based physical activity (PA) intervention that systematically trains partners in skills to support the survivor in PA initiation and maintenance strategies.

Couples randomized to Arm 1 (the Couples-Based Physical Activity Intervention) will receive four 60-minute intervention sessions via videoconference with Duke staff. Study staff will provide couples with instructions for use of the iPad computer (if provided by the study) and videoconference software which will be used to deliver the intervention sessions. Couples will also be provided with contact information for technical support. The first 3 sessions will be conducted weekly, with a booster session occurring approximately one month later. The intervention will include components to (a) encourage couples' favorable outcome expectations about the benefits of working together to initiate and maintain increases in PA, (b) build their confidence that they can work together to accomplish their goals, and (c) help them identify and use communal strategies, such as couple communication and joint decision making about goals and plans for increasing physical activity, and working through barriers to making these changes. Finally, the intervention will incorporate important behavior change techniques that have been found to help people change their exercise behavior, such as goal setting, self-monitoring of behavior, and prompts for practice, adapting them to a communal coping approach. Treatment sessions will be audio recorded for QA purposes.

Those randomized to Arm 2 (waitlist control) will have the option to receive the intervention after they complete the follow-up survey. This version of the intervention will not include the booster session, so will last approximately 1 month in total. If they choose to receive the intervention, they will be provided with a tablet computer if they do not have one.

Being tested
Physical Activity Intervention
Keywords
cancer survivor, breast cancer, prostate cancer, couples
Medical subject headings
Motor Activity, Breast Neoplasms, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity InterventionBehavioural

    To develop and test a couple-based physical activity intervention among cancer survivors and their partners

Study groups in NCT03266718
Study groupRoleWhat they receive
Physical Activity InterventionOtherCouples will receive four 60-minute intervention sessions via videoconference with Duke staff. Study staff will provide couples with instructions for use of the iPad computer and videoconference software which will be used to deliver the intervention sessions.The first 3 sessions will be conducted weekly, with a booster session occurring approximately one month later.
Receives: Behavioral: Physical Activity Intervention
Waitlist controlOtherCouples will have the option to receive the intervention after they complete the follow-up survey. This version of the intervention will not include the booster session, so will last approximately 1 month in total. If they choose to receive the intervention, they will be provided with a tablet computer if they do not have one.
Receives: Behavioral: Physical Activity Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates for non-eligibility.

    Measured: 2 months after baseline survey

  2. Feasibility of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates of refusal.

    Measured: 2 months after baseline survey

  3. Acceptability of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates for non-eligibility.

    Measured: 2 months after baseline survey

  4. Acceptability of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates of refusal.

    Measured: 2 months after baseline survey

Secondary outcomes (5)
  1. Efficacy as measured by steps taken

    Measured: 2 months after baseline survey

  2. Quality of life as measured by surveys

    Measured: 2 months after baseline survey

  3. Self -efficacy for achieving and maintaining physical activity goals as measured by surveys

    Measured: 2 months after baseline survey

  4. Perceived partner support for physical activity as measured by surveys

    Measured: 2 months after baseline survey

  5. Quality of the survivor-partner relationship as measured by surveys

    Measured: 2 months after baseline survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start1 Jul 2015
  3. Primary completion26 Sep 2016
  4. Study completion11 Dec 2016

Resources

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
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03266718
Sponsor's protocol ID
Pro00060926
Status last verified
Aug 2017
First submitted
15 Aug 2017
Last updated
30 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: We will not share IPD unless requested by Duke Researchers only.

Questions about this trial

What is this clinical trial studying?

A study testing Physical Activity Intervention in people with Physical Activity and Cancer Survivor, run by Duke University.

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 1 inclusion and 1 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

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 of a couple-based physical activity intervention for cancer survivors as measured by a composite score of total number of couples screened and rates for non-eligibility. (time frame: 2 months after baseline survey). The study lists 4 primary outcomes in all. 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 30 Aug 2017.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in