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CompletedNCT04559854MACUpdated Jun 25, 2025Results posted

Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer

An interventional study of Mindful After Cancer in Breast Cancer and Gynecologic Cancer, sponsored by Oregon State University. Completed at 1 site in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2025-06-25.

Sponsored by Oregon State University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2019, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years to 89 Years
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Cancer
  • Gynecologic Cancer

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03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 22 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Oregon State University is the lead sponsor of 37 studies on the registry; 3 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 to 89 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

- Stage 0 (carcinoma in situ)

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Mindful After Cancer

    Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.

    Behavioral: Mindful After Cancer

Interventions

  • BehavioralMindful After Cancer

    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.

06

What researchers measure

Primary outcomes

  1. Feasibility/ Enrollment in the Study

    Percentage of participants enrolled of those eligible

    Time frame: Baseline (T1)

  2. Feasibility/ Retention in the Study

    Number and percentage of participants completing all assessments

    Time frame: 1 month post-intervention (T2)

  3. Feasibility/ Retention in the Intervention

    Number and percentage attending at least 6 of 8 sessions

    Time frame: 1 month post-intervention (T2)

  4. 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.

    Time frame: 1 month post-intervention (T2)

Secondary outcomes

  1. 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.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  2. 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.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  3. 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.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  4. Change From Baseline Body Image at 1 Month

    Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  5. Change From Baseline Body Appreciation at 1 Month

    Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  6. 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.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  7. 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

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  8. 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.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  9. 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.

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

  10. 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

    Time frame: Baseline (T1) and 1 month post-intervention (T2)

07

Results

Posted Jun 25, 2025

Participant flow

Participant flow — Overall Study
MilestoneMindful After Cancer
Started22
Completed22
Not completed0

Outcome measures

PrimaryFeasibility/ Enrollment in the Study

Percentage of participants enrolled of those eligible

Time frame:
Baseline (T1)
Reported as:
Number · Percentage enrolled of eligible
Feasibility/ Enrollment in the Study
Percentage enrolled of eligibleMindful After Cancer
Feasibility/ Enrollment in the Study78.6
PrimaryFeasibility/ Retention in the Study

Number and percentage of participants completing all assessments

Time frame:
1 month post-intervention (T2)
Reported as:
Count of participants · Participants
Feasibility/ Retention in the Study
ParticipantsMindful After Cancer
Feasibility/ Retention in the Study22
PrimaryFeasibility/ Retention in the Intervention

Number and percentage attending at least 6 of 8 sessions

Time frame:
1 month post-intervention (T2)
Reported as:
Count of participants · Participants
Feasibility/ Retention in the Intervention
ParticipantsMindful After Cancer
Feasibility/ Retention in the Intervention18
PrimaryAcceptability 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.

Time frame:
1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Acceptability of the Intervention
score on a scaleMindful After Cancer
Acceptability of the Intervention75.5 ± 22.9
SecondaryChange 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.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Interest in Sexual Activity at 1 Month
score on a scaleMindful After Cancer
T1 Mean, SD4.4 ± 1.4
T2 Mean, SD5.0 ± 1.7
SecondaryChange 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.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Satisfaction With Sex Life at 1 Month
score on a scaleMindful After Cancer
T1 Mean, SD35 ± 6.8
T2 Mean, SD37.3 ± 7.4
SecondaryChange 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.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Self-efficacy at 1 Month
score on a scaleMindful After Cancer
Change From Baseline Self-efficacy at 1 Month0.06 (-0.87 to 0.98)
SecondaryChange From Baseline Body Image at 1 Month

Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Body Image at 1 Month
score on a scaleMindful After Cancer
T1 Mean, SD15.2 ± 7.1
T2 Mean, SD13.1 ± 8.2
SecondaryChange From Baseline Body Appreciation at 1 Month

Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Body Appreciation at 1 Month
score on a scaleMindful After Cancer
T1 Mean, SD3.2 ± 0.7
T2 Mean, SD3.6 ± 0.7
SecondaryChange From Baseline Anxiety at 1 Month

PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Anxiety at 1 Month
score on a scaleMindful After Cancer
T1 Mean, SD15.0 ± 5.4
T2 Mean, SD12.9 ± 4.4
SecondaryChange 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

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Depression at 1 Month
score on a scaleMindful After Cancer
T1 Mean, SD16.3 ± 9.0
T2 Mean, SD13.9 ± 11.3
SecondaryChange 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.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a subscale
Change in Facets of Baseline Mindfulness at 1 Month
score on a subscaleMindful After Cancer
Observe subscale T1 Mean, SD10.8 ± 2.1
Observe subscale T2 Mean, SD9.6 ± 0.9
Acting with Awareness subscale T1 Mean, SD9.3 ± 2.0
Acting with Awareness subscale T2 Mean, SD10.8 ± 2.2
Non-reactivity subscale T1 Mean, SD9.7 ± 2.4
Non-reactivity subscale T2 Mean, SD8.9 ± 1.0
Non-judging subscale T1 Mean, SD10.7 ± 2.4
Non-judging subscale T2 Mean, SD8.8 ± 1.4
Describing subscale T1 Mean, SD10.3 ± 2.4
Describing subscale T2 Mean, SD10.0 ± 1.5
SecondaryChange 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.

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · mean score on a scale
Change From Baseline Self-compassion at 1 Month
mean score on a scaleMindful After Cancer
T1 Mean, SD3.0 ± 0.7
T2 Mean, SD2.9 ± 0.2
SecondaryChange From Baseline Relationship Quality at 1 Month

Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality

Time frame:
Baseline (T1) and 1 month post-intervention (T2)
Reported as:
Mean · score on a scale
Change From Baseline Relationship Quality at 1 Month
score on a scaleMindful After Cancer
T1 Mean, SD24.0 ± 6.5
T2 Mean, SD25.3 ± 5.7

Adverse events

Collected over Duration of study, approximately 3-4 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Mindful After Cancer0/22 (0%)0/22 (0%)0/22 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Mindful After Cancer
Mean53.2 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)Mindful After Cancer
Female22
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Mindful After Cancer
Hispanic or Latino1
Not Hispanic or Latino21
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Mindful After Cancer
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White20
More than one race1
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(Participants)Mindful After Cancer
United States22
Education
Education(Participants)Mindful After Cancer
College graduate20
Did not graduate from college2
Income
Income(Participants)Mindful After Cancer
< $50,000 annual income8
> $50,000 annual income14
Employment Status
Employment Status(Participants)Mindful After Cancer
Employed15
Unemployed7

10 further baseline measures are reported on the registry.

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Study locations

1 site
  • Oregon State University
    Corvallis, Oregon 97331, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 17, 2020

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04559854
Lead sponsor
Oregon State University
Collaborators
OHSU Knight Cancer Institute
Responsible party
Jessica Gorman (Associate Professor, Oregon State University) — Principal investigator
First posted
Sep 23, 2020
Start date
Jul 1, 2019
Primary completion
Oct 1, 2020
Completion
Oct 5, 2020
Results posted
Jun 25, 2025
Last update
Jun 25, 2025

Study contacts

Jessica R Gorman, PhD, MPH
principal investigator · Oregon State University

Oversight

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

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