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

NCT03266718 | Completed

• 1 other identifier: Pro00060926
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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 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.

Conditions

Physical Activity; Cancer Survivor

Keywords

cancer survivor; breast cancer; prostate cancer; couples

Outcome Measures

Primary Outcomes (4)

• 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.

  2 months after baseline survey

• 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.

  2 months after baseline survey

• 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.

  2 months after baseline survey

• 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.

  2 months after baseline survey

Secondary Outcomes (5)

• Efficacy as measured by steps taken

  2 months after baseline survey

• Quality of life as measured by surveys

  2 months after baseline survey

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

  2 months after baseline survey

• Perceived partner support for physical activity as measured by surveys

  2 months after baseline survey

• Quality of the survivor-partner relationship as measured by surveys

  2 months after baseline survey

Study Arms (2)

Physical Activity Intervention

OTHER

Couples 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.

Behavioral: Physical Activity Intervention

Waitlist control

OTHER

Couples 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.

Behavioral: Physical Activity Intervention

Interventions

Physical Activity Intervention BEHAVIORAL

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

Physical Activity Intervention; Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Motor Activity; Breast Neoplasms; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Behavior; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Laura Porter, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: August 30, 2017
• Study Start: July 1, 2015
• Primary Completion: September 26, 2016
• Study Completion: December 11, 2016
• Last Updated: August 30, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share