Breast CancerMACNCT04559854
Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer
A study testing Mindful After Cancer in people with Breast Cancer and Gynecologic Cancer, run by Oregon State University at 1 site in United States.
Trial summary
The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and… Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Breast Cancer, Gynecologic Cancer
- What is being tested?
- Mindful After Cancer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2019to 5 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
- Completed primary cancer treatment
- English speaking
- Have access to a computer, smart phone, or tablet with internet access
- Ability to spend 15-30 minutes per day on program activities
Who cannot join
- Stage 0 (carcinoma in situ)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being
The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.
Read the detailed description
The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.
- Conditions
- Breast Cancer, Gynecologic Cancer
- Being tested
- Mindful After Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful After CancerBehavioural
The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.
| Study group | Role | What they receive |
|---|---|---|
| Mindful After Cancer | Experimental | Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. Receives: Behavioral: Mindful After Cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility/ Enrollment in the Study
Percentage of participants enrolled of those eligible
Measured: Baseline (T1)
Feasibility/ Retention in the Study
Number and percentage of participants completing all assessments
Measured: 1 month post-intervention (T2)
Feasibility/ Retention in the Intervention
Number and percentage attending at least 6 of 8 sessions
Measured: 1 month post-intervention (T2)
Acceptability of the Intervention
Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.
Measured: 1 month post-intervention (T2)
Secondary outcomes (10)
Change From Baseline Interest in Sexual Activity at 1 Month
PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Satisfaction With Sex Life at 1 Month
New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Self-efficacy at 1 Month
Self-efficacy for Managing Chronic Disease Scale (adapted). 6 items. Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Body Image at 1 Month
Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Body Appreciation at 1 Month
Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Anxiety at 1 Month
PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Depression at 1 Month
Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change in Facets of Baseline Mindfulness at 1 Month
Five-Facet Mindfulness Questionnaire (FFMQ-15). 15 items with 5 sub-scales: Observe, Describe; Act with Awareness; Non-Judgement, Non-Reactivity. Sub-scale score range 3-15. Higher score indicates greater mindfulness.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Self-compassion at 1 Month
Self-Compassion Scale short form. 12 items. Total score is calculated based on mean of item responses (each item ranges 1-5). Higher mean score indicates greater self-compassion.
Measured: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Relationship Quality at 1 Month
Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality
Measured: Baseline (T1) and 1 month post-intervention (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jul 2019
- Primary completion1 Oct 2020
- Study completion5 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- OHSU Knight Cancer Institute
- Responsible party
- Principal investigator, Jessica Gorman, Oregon State University
- Investigators
- Jessica R Gorman, PhD, MPH, Principal investigator, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559854
- Sponsor's protocol ID
- IRB-2019-003
- Acronym
- MAC
- Status last verified
- Jun 2025
- First submitted
- 11 Sep 2020
- Last updated
- 25 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful After Cancer Study: Fostering Positive Body Image, Sexual Health, and Well-being
- ClinicalTrials.gov ID
- NCT04559854
- Acronym / sponsor ID
- MAC / IRB-2019-003
- Conditions
- Breast Cancer, Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- OHSU Knight Cancer Institute
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 5 Oct 2020 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Posted 25 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this study are to: 1) adapt a mindfulness-based therapy program designed to help women manage their sexual and body image concerns after cancer (Mindful After Cancer, MAC) to a videoconference format and 2) assess the feasibility, acceptability, and preliminary effects of the program among breast and gynecologic cancer survivors.
Detailed description
The specific aims are: 1) Assess the feasibility of the MAC program when delivered via videoconference and 2) Assess preliminary effects of the the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindful After Cancer | Experimental | Behavioral: Mindful After CancerParticipants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of breast or gynecologic cancer at least one year prior to enrollment
- Completed primary cancer treatment
- English speaking
- Have access to a computer, smart phone, or tablet with internet access
- Ability to spend 15-30 minutes per day on program activities
Key exclusion criteria (1 listed)
- Stage 0 (carcinoma in situ)
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 |
|---|---|---|
| Mindful After CancerThe intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions. | Behavioural | Mindful After Cancer |
Primary outcome
Feasibility/ Enrollment in the Study
Time frame: Baseline (T1)
Percentage of participants enrolled of those eligible
Feasibility/ Retention in the Study
Time frame: 1 month post-intervention (T2)
Number and percentage of participants completing all assessments
Feasibility/ Retention in the Intervention
Time frame: 1 month post-intervention (T2)
Number and percentage attending at least 6 of 8 sessions
Acceptability of the Intervention
Time frame: 1 month post-intervention (T2)
Endorsement of 10 items characterizing acceptability of the intervention (e.g., the program met my expectations). Range 10-100. Higher score indicates better acceptability.
10 secondary outcomes
Change From Baseline Interest in Sexual Activity at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Satisfaction With Sex Life at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Self-efficacy at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Body Image at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Body Appreciation at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Anxiety at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Depression at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change in Facets of Baseline Mindfulness at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Self-compassion at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Change From Baseline Relationship Quality at 1 Month
Time frame: Baseline (T1) and 1 month post-intervention (T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jessica R Gorman, PhD, MPH principal investigator
Oregon State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful After Cancer in people with Breast Cancer and Gynecologic Cancer, run by Oregon State University 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 5 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 25 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 25 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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/ Enrollment in the Study (time frame: Baseline (T1)). 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 25 Jun 2025.