Gynecologic CancersPhase 1MACNCT07055854
Virtual Mindful After Cancer (MAC) Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors
A Phase 1 study testing Mindful After Cancer Program in people with Gynecologic Cancers and Breast Cancer, run by Oregon State University at 3 sites in United States.
Trial summary
The goal of this study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers, Breast Cancer
- What is being tested?
- Mindful After Cancer Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Sep 2025to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Diagnosed with female breast or gynecologic cancer at stage I-IV
- Diagnosed at least 6 months ago
- At least one sexual concern in a validated screener
- Access to high speed internet via smart phone, tablet, and/or computer
Who cannot join
- Those who do not comprehend English since the MAC program is only available in English.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Samaritan Pastega Regional Cancer Center
Corvallis, Oregon, 97330
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
About this study
Official title: Virtual Mindful After Cancer Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors
The goal of this study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns.
The main study aims are to:
Read more
- Develop effective plans for recruiting participants across multiple sites
- Evaluate participation in the program and surveys
- Develop plans to train and supervise the professionals who will deliver the program.
Researchers will compare study recruitment across three sites, aiming to identify the most efficient approach for a larger future trial.
Participants who are randomly assigned to receive the MAC program will receive access to the 8-week program delivered by a trained mindfulness coach using videoconference and online materials. They will asked to participate in an interview about their experiences at the end of the program.
Participants who are not randomly assigned to the MAC program will receive access to the program's educational materials after completing the final survey.
All study participants will be asked to complete 3 online surveys. Participants randomly assigned to the MAC Program will also be asked to complete a one-on-one interview about their experience in the program.
- Conditions
- Gynecologic Cancers, Breast Cancer
- Being tested
- Mindful After Cancer Program
- Keywords
- cancer survivorship, mindfulness, sexual health, intervention
- 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 Cancer ProgramBehavioural
The Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Not described |
| Intervention | Experimental | Not described Receives: Behavioral: Mindful After Cancer Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Accrual Rate- The percent of eligible candidates who enroll
Measured: Baseline
Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist.
Adherence to the manual is assessed by independent review of audio-recorded intervention sessions using a checklist of material to be covered in each session.
Measured: Up to 1 week post-intervention.
Retention Rate - The percent of enrolled participants who complete all study surveys
Measured: Up to the 3 month post-intervention survey at week 22.
Secondary outcomes (1)
MAC intervention Drop Out- As measured by session attendance.
Percentage of enrolled participants who stop attending the MAC intervention arm after attending the first session.
Measured: Up to completion of the 8-week MAC intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start30 Sep 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Jessica Gorman, Oregon State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055854
- Sponsor's protocol ID
- HE-2023-492
- Other IDs
- 1R34CA286710
- Acronym
- MAC
- Status last verified
- Oct 2026
- First submitted
- 10 Jun 2025
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Mindful After Cancer Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors
- ClinicalTrials.gov ID
- NCT07055854
- Acronym / sponsor ID
- MAC / HE-2023-492
- Conditions
- Gynecologic Cancers, Breast Cancer
- Keywords
- cancer survivorship, mindfulness, sexual health, intervention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Oregon State UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Jul 2025 (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 study is to plan for a large scale evaluation of a program called Mindful After Cancer, or MAC. The MAC Program provides training in mindfulness, educational material about sexual health after cancer, and support to cancer survivors experiencing sexual and body image concerns.
The main study aims are to:
- Develop effective plans for recruiting participants across multiple sites
- Evaluate participation in the program and surveys
- Develop plans to train and supervise the professionals who will deliver the program.
Researchers will compare study recruitment across three sites, aiming to identify the most efficient approach for a larger future trial.
Participants who are randomly assigned to receive the MAC program will receive access to the 8-week program delivered by a trained mindfulness coach using videoconference and online materials. They will asked to participate in an interview about their experiences at the end of the program.
Participants who are not randomly assigned to the MAC program will receive access to the program's educational materials after completing the final survey.
All study participants will be asked to complete 3 online surveys. Participants randomly assigned to the MAC Program will also be asked to complete a one-on-one interview about their experience in the program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | – |
| Intervention | Experimental | Behavioral: Mindful After Cancer Program |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 18 years old
- Diagnosed with female breast or gynecologic cancer at stage I-IV
- Diagnosed at least 6 months ago
- At least one sexual concern in a validated screener
- Access to high speed internet via smart phone, tablet, and/or computer
Key exclusion criteria (1 listed)
- Those who do not comprehend English since the MAC program is only available in English.
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 Cancer ProgramThe Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns. | Behavioural | Intervention |
Primary outcome
Recruitment Accrual Rate- The percent of eligible candidates who enroll
Time frame: Baseline
Intervention Fidelity- The percent of required topics covered during intervention sessions as measured by completion of a checklist.
Time frame: Up to 1 week post-intervention.
Adherence to the manual is assessed by independent review of audio-recorded intervention sessions using a checklist of material to be covered in each session.
Retention Rate - The percent of enrolled participants who complete all study surveys
Time frame: Up to the 3 month post-intervention survey at week 22.
1 secondary outcome
MAC intervention Drop Out- As measured by session attendance.
Time frame: Up to completion of the 8-week MAC intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mindful After Cancer Program in people with Gynecologic Cancers and Breast Cancer, run by Oregon State University at 3 sites 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: under way, not looking for participants, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Recruitment Accrual Rate- The percent of eligible candidates who enroll (time frame: Baseline). The study lists 3 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 8 Oct 2026.