Cancer DiagnosisNCT04471363
Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity
An observational study of Cancer Diagnosis and Couples, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Diagnosis, Couples
- What is being tested?
- Cancer-Specific Exercise education
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2018to 7 May 2024
- Phase
- Observational
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
Official title: Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity Intervention: A Needs Assessment Study
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.
Read the detailed description
This study will assess multiple predictors of couples-based physical activity interest among both survivors and partners including gender, age, current exercise, relationship satisfaction and partner support for exercise. Additionally, this study will include an experimental manipulation in which half of the sample will be randomized to receive cancer-specific exercise education.
- Conditions
- Cancer Diagnosis, Couples
- Being tested
- Cancer-Specific Exercise education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cancer-Specific Exercise educationBehavioural
An audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cancer-Specific Exercise education | |
| Control | All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start14 Jun 2018
- Primary completion8 Feb 2019
- Study completion7 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer DiagnosisStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471363
- Sponsor's protocol ID
- 17-1649.cc
- Status last verified
- May 2024
- First submitted
- 10 Jul 2020
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Survivors and Their Romantic Partners' Preferences for a Couples-based Physical Activity Intervention: A Needs Assessment Study
- ClinicalTrials.gov ID
- NCT04471363
- Acronym / sponsor ID
- 17-1649.cc
- Conditions
- Cancer Diagnosis, Couples
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 8 Feb 2019 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 15 Jul 2020 (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.
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.
Detailed description
This study will assess multiple predictors of couples-based physical activity interest among both survivors and partners including gender, age, current exercise, relationship satisfaction and partner support for exercise. Additionally, this study will include an experimental manipulation in which half of the sample will be randomized to receive cancer-specific exercise education.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer Specific Exercise Education | – | Behavioral: Cancer-Specific Exercise educationThis 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. |
| Control | – | –All participants will be asked to indicate their exercise knowledge, self-efficacy, beliefs and intentions. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
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 |
|---|---|---|
| Cancer-Specific Exercise educationAn audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples. | Behavioural | Cancer Specific Exercise Education |
Primary outcome
Questionnaire to determine predictors
Time frame: 45 minutes
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.
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 10 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Diagnosis and Couples, run by University of Colorado, Denver 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?
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 10 May 2024. 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?
Questionnaire to determine predictors (time frame: 45 minutes). 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 10 May 2024.