ClinicalTrials.gg
Active, not recruitingNCT07055854MACUpdated Oct 8, 2026

Virtual Mindful After Cancer (MAC) Intervention to Promote Sexual Health for Breast and Gynecologic Cancer Survivors

A Phase 1 interventional study of Mindful After Cancer Program in Gynecologic Cancers and Breast Cancer, sponsored by Oregon State University. Active, not recruiting at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.

Sponsored by Oregon State University · Phase 1, Interventional, and Supportive care

Updated Oct 8, 2026Now Active, not recruitingGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

The main study aims are to:

  1. Develop effective plans for recruiting participants across multiple sites
  2. Evaluate participation in the program and surveys
  3. 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.

02

Conditions studied

  • Gynecologic Cancers
  • Breast Cancer

Browse trials for

Keywords

  • cancer survivorship
  • mindfulness
  • sexual health
  • intervention
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 60 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Oregon State University is the lead sponsor of 38 studies on the registry; 2 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 4 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Those who do not comprehend English since the MAC program is only available in English.
05

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    Usual Care
  • Experimental
    Intervention

    Behavioral: Mindful After Cancer Program

Interventions

  • BehavioralMindful After Cancer Program

    The Mindful After Cancer Program provides education, mindfulness training, and peer support to help cancer survivors navigate sexual and body image concerns.

06

What researchers measure

Primary outcomes

  1. Recruitment Accrual Rate- The percent of eligible candidates who enroll

    Time frame: Baseline

  2. 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.

    Time frame: Up to 1 week post-intervention.

  3. 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.

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.

    Time frame: Up to completion of the 8-week MAC intervention.

Other outcomes

  1. Exploratory outcome: Interest in sexual activity as measured by the interest in sexual activity domain from the PROMIS Sexual Function and Satisfaction Scale.

    To compare sexual interest longitudinally after enrollment between those receiving MAC and those receiving usual care. The sexual interest domain has 2 items, Range 2-10. Higher score indicates more interest in sexual activity.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  2. Exploratory Outcome: Body Appreciation as measured by the Body Appreciation Scale.

    To compare body appreciation longitudinally after enrollment between those receiving MAC and those receiving usual care. The Body Appreciation Scale has13 items, Range 13-65. Higher score indicates more positive body appreciation.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  3. Exploratory Outcome: Sexual Satisfaction as measured by the Global Measure of Sexual Satisfaction scale (GMSEX).

    To compare sexual satisfaction longitudinally after enrollment between those receiving MAC and those receiving usual care. The GMSEX scale has 5 items, Range 5-35. Higher score indicates higher level of sexual satisfaction.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  4. Exploratory outcome: Self-Efficacy as measured by the Self-Efficacy for Managing Chronic Disease Scale (adapted).

    To compare self-efficacy for managing sexual health in chronic disease longitudinally after enrollment between those receiving MAC and those receiving usual care. The adapted self-efficacy for managing chronic disease scale has 6 items, Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  5. Exploratory outcome: Self-compassion as measured by the Self-Compassion Scale Short Form (SCS-SF).

    To compare self-compassion longitudinally after enrollment between those receiving MAC and those receiving usual care. The SCS-SF has 12 items, Range 12-60. Higher score indicates greater self-compassion for managing chronic disease scale has 6 items, Range 6-60. Higher score indicates better self-efficacy for managing sexual health after cancer.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  6. Exploratory outcome: Mindfulness as measured by the Five-Facet Mindfulness Questionnaire (FFMQ-15).

    To compare mindfulness longitudinally after enrollment between those receiving MAC and those receiving usual care. The FFMQ-15 has 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.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  7. Exploratory outcome: Social support as measured by the modified Medical Outcomes Study Social Support Survey (mMOS-SS).

    To compare social support longitudinally after enrollment between those receiving MAC and those receiving usual care. The mMOS-SS has 8 items, Range 1-5. The score for mMOS-SS is calculated as the average score of subscale items transformed to a zero to 100 scale, with higher scores indicating more support.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  8. Exploratory outcome: Depressive Symptoms as measured by the Patient Health Questionnaire (PHQ-8)

    To compare depressive symptoms longitudinally after enrollment between those receiving MAC and those receiving usual care. The PHQ-8 has 8 items, Range 0-24. Higher scores indicate higher levels of depressive symptoms.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  9. Exploratory outcome: Anxiety as measured by the PROMIS Emotional Distress Anxiety Short Form 6a.

    To compare anxiety longitudinally after enrollment between those receiving MAC and those receiving usual care. The PROMIS Emotional Distress Anxiety Short Form 6a has 6 items, Range 6-30. Higher scores indicate higher levels of anxiety.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  10. Exploratory outcome: Quality of life as measured by the PROMIS Global Health 10.

    To compare quality of life longitudinally after enrollment between those receiving MAC and those receiving usual care. The PROMIS Global Health 10 has 10 items, Range 10-50. Higher scores indicate better functioning.

    Time frame: Up to the 3 month post-intervention survey at week 22.

  11. Exploratory outcome: Sexual function (Lubrication) as measured by the lubrication domain from the PROMIS Sexual Function and Satisfaction Scale.

    To compare vaginal lubrication longitudinally after enrollment between those receiving MAC and those receiving usual care. The vaginal lubrication domain has 3 items, Range 3-15. Higher score indicates more vaginal lubrication.

    Time frame: From Baseline up to the 3 month post-intervention survey at week 22.

  12. Exploratory outcome: Sexual function (Vaginal Discomfort) as measured by the vaginal discomfort domain from the PROMIS Sexual Function and Satisfaction Scale.

    To compare vaginal discomfort longitudinally after enrollment between those receiving MAC and those receiving usual care. The vaginal discomfort domain has 2 items, Range 2-10. Higher score indicates more vaginal discomfort.

    Time frame: From Baseline up to the 3 month post-intervention survey at week 22.

  13. Exploratory outcome: Sexual function (Labia Discomfort) as measured by the labia discomfort domain from the PROMIS Sexual Function and Satisfaction Scale.

    To compare labia discomfort longitudinally after enrollment between those receiving MAC and those receiving usual care. The labia discomfort domain has 2 items, Range 2-10. Higher score indicates more labia discomfort.

    Time frame: From Baseline up to the 3 month post-intervention survey at week 22.

  14. Exploratory outcome: Sexual function (Clitoral Discomfort) as measured by the clitoral discomfort domain from the PROMIS Sexual Function and Satisfaction Scale.

    To compare clitoral discomfort longitudinally after enrollment between those receiving MAC and those receiving usual care. The clitoral discomfort domain has 2 items, Range 2-10. Higher score indicates more clitoral discomfort.

    Time frame: From Baseline up to the 3 month post-intervention survey at week 22.

  15. Exploratory outcome: Sexual function (Orgasm ability) as measured by the orgasm ability domain from the PROMIS Sexual Function and Satisfaction Scale.

    To compare orgasm ability longitudinally after enrollment between those receiving MAC and those receiving usual care. The orgasm ability domain has 1 item, Range 1-5. Higher score indicates more orgasm ability.

    Time frame: From Baseline up to the 3 month post-intervention survey at week 22.

  16. Exploratory outcome: Sexual function (Orgasm pleasure) as measured by the orgasm pleasure domain from the PROMIS Sexual Function and Satisfaction Scale.

    To compare orgasm pleasure longitudinally after enrollment between those receiving MAC and those receiving usual care. The orgasm pleasure domain has 2 items, Range 2-10. Higher score indicates more orgasm pleasure.

    Time frame: From Baseline up to the 3 month post-intervention survey at week 22.

07

Study locations

3 sites
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2025 (actual). Primary completion is estimated for Dec 2026, 15 months after the start.

Of 371 non-industry phase 1 interventional studies under Breast Neoplasms, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 77. This study's planned 15 months is below that.

Counting every sponsor, half of 759 studies reached it within 44 months; a quarter within 25 and three quarters within 66.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2025
First posted
Jul 9, 2025
StartActual
Sep 30, 2025
Primary completionEst.
Dec 31, 2026
CompletionEst.
Dec 31, 2026
Last update
Oct 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Active, not recruiting
changed Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    Recruiting→Active, not recruiting
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07055854
Lead sponsor
Oregon State University
Responsible party
Jessica Gorman (Associate Professor, Oregon State University) — Principal investigator
First posted
Jul 9, 2025
Start date
Sep 30, 2025
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Oct 8, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion