NCT04471363

Brief Summary

The goal of this research is to explore cancer survivors' and their romantic partners' interest in a couples-based physical activity intervention and whether cancer-specific exercise education influences exercise beliefs and intentions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
448

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 14, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

8 months

First QC Date

July 10, 2020

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Questionnaire to determine predictors

    All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions. Participation in this study will last approximately 45 minutes, and all data will be collected using an on-line Redcap survey. Predictors to be examined are gender, age, current exercise, relationship satisfaction and partner support for exercise.

    45 minutes

Study Arms (2)

Cancer Specific Exercise Education

This subsample of participants will watch an audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.

Behavioral: Cancer-Specific Exercise education

Control

All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions.

Interventions

An audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.

Cancer Specific Exercise Education

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

We are interested in hearing from cancer survivors and romantic partners from diverse backgrounds. This study is open to both active and inactive individuals. Cancer survivors can have had any type of cancer, cancer treatment, or recurrence(s). Further, we are not limiting participation based on time since diagnosis. Romantic partners do not need to be married, co-habituating, or in a relationship for a specific time-period in order to be eligible. Additionally, this study will not exclude couples in which both individuals are cancer survivors. Lastly, while we prefer both partners within a couple participate, we will not exclude individual participation.

In order to be eligible, individuals must answer "Yes" to all of the following statements: * I am a cancer survivor OR I am the romantic partner of a cancer survivor * I am not currently undergoing chemotherapy, radiation or surgery nor do I have plans to undergo chemotherapy, radiation or a cancer-related surgery in the next 6 months * I am in a committed, romantic relationship * I have access to a computer or tablet with internet * I have an email address that I am willing to share with the study team * I am at least 18 years of age and less than 90 years of age

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 15, 2020

Study Start

June 14, 2018

Primary Completion

February 8, 2019

Study Completion

May 7, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations