Trial Outcomes & Findings for Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer (NCT NCT04559854)
NCT ID: NCT04559854
Last Updated: 2025-06-25
Results Overview
Percentage of participants enrolled of those eligible
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
Baseline (T1)
Results posted on
2025-06-25
Participant Flow
Participant milestones
| Measure |
Mindful After Cancer
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Overall Study
STARTED
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22
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Overall Study
COMPLETED
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22
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindful After Cancer: A Mindfulness-based Therapy Intervention for Sexual Health After Cancer
Baseline characteristics by cohort
| Measure |
Mindful After Cancer
n=22 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Age, Continuous
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53.2 years
STANDARD_DEVIATION 9.4 • n=5 Participants
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Sex: Female, Male
Female
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22 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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21 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
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Race (NIH/OMB)
White
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20 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
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Region of Enrollment
United States
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22 Participants
n=5 Participants
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Education
College graduate
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20 Participants
n=5 Participants
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Education
Did not graduate from college
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2 Participants
n=5 Participants
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Income
< $50,000 annual income
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8 Participants
n=5 Participants
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Income
> $50,000 annual income
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14 Participants
n=5 Participants
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Employment Status
Employed
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15 Participants
n=5 Participants
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Employment Status
Unemployed
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7 Participants
n=5 Participants
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Health Insurance Coverage
Yes
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22 Participants
n=5 Participants
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Health Insurance Coverage
No
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0 Participants
n=5 Participants
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Relationship status
Partnered
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15 Participants
n=5 Participants
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Relationship status
Not Partnered
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7 Participants
n=5 Participants
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Sexual Orientation
Bisexual
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4 Participants
n=5 Participants
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Sexual Orientation
Heterosexual
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18 Participants
n=5 Participants
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Cancer Type
Breast
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21 Participants
n=5 Participants
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Cancer Type
Ovarian
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1 Participants
n=5 Participants
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Self-Reported Cancer Stage
I
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12 Participants
n=5 Participants
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Self-Reported Cancer Stage
II
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5 Participants
n=5 Participants
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Self-Reported Cancer Stage
III
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3 Participants
n=5 Participants
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Self-Reported Cancer Stage
IV
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1 Participants
n=5 Participants
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Self-Reported Cancer Stage
Unknown
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1 Participants
n=5 Participants
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Age at Cancer Diagnosis
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47.0 years
STANDARD_DEVIATION 8.1 • n=5 Participants
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Time Since Cancer Diagnosis
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6.0 years
STANDARD_DEVIATION 5.9 • n=5 Participants
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Has Biological Child(ren)
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15 Participants
n=5 Participants
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Sexually Active
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13 Participants
n=5 Participants
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Current Contraception Use
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2 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline (T1)Percentage of participants enrolled of those eligible
Outcome measures
| Measure |
Mindful After Cancer
n=22 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Feasibility/ Enrollment in the Study
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78.6 Percentage enrolled of eligible
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PRIMARY outcome
Timeframe: 1 month post-intervention (T2)Number and percentage of participants completing all assessments
Outcome measures
| Measure |
Mindful After Cancer
n=22 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Feasibility/ Retention in the Study
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22 Participants
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PRIMARY outcome
Timeframe: 1 month post-intervention (T2)Number and percentage attending at least 6 of 8 sessions
Outcome measures
| Measure |
Mindful After Cancer
n=22 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Feasibility/ Retention in the Intervention
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18 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mindful After Cancer
n=22 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Acceptability of the Intervention
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75.5 score on a scale
Standard Deviation 22.9
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)PROMIS Sexual Function and Satisfaction 2.0. 2 items. Range 2-10. Higher score indicates more interest in sexual activity.
Outcome measures
| Measure |
Mindful After Cancer
n=20 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Interest in Sexual Activity at 1 Month
T1 Mean, SD
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4.4 score on a scale
Standard Deviation 1.4
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Change From Baseline Interest in Sexual Activity at 1 Month
T2 Mean, SD
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5.0 score on a scale
Standard Deviation 1.7
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)New Sexual Satisfaction Scale- Short Form (NSSS-S). 12 items. Range 12-60. Higher score indicates more sexual satisfaction.
Outcome measures
| Measure |
Mindful After Cancer
n=6 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Satisfaction With Sex Life at 1 Month
T1 Mean, SD
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35 score on a scale
Standard Deviation 6.8
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Change From Baseline Satisfaction With Sex Life at 1 Month
T2 Mean, SD
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37.3 score on a scale
Standard Deviation 7.4
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)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.
Outcome measures
| Measure |
Mindful After Cancer
n=20 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Self-efficacy at 1 Month
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0.06 score on a scale
Interval -0.87 to 0.98
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)Body Image Scale. 10 items. Range 0-30. Higher score indicates poorer body image.
Outcome measures
| Measure |
Mindful After Cancer
n=21 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Body Image at 1 Month
T1 Mean, SD
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15.2 score on a scale
Standard Deviation 7.1
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Change From Baseline Body Image at 1 Month
T2 Mean, SD
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13.1 score on a scale
Standard Deviation 8.2
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)Body Appreciation Scale. 13 items. Range 13-65. Higher score indicates more positive body appreciation.
Outcome measures
| Measure |
Mindful After Cancer
n=21 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Body Appreciation at 1 Month
T1 Mean, SD
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3.2 score on a scale
Standard Deviation 0.7
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Change From Baseline Body Appreciation at 1 Month
T2 Mean, SD
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3.6 score on a scale
Standard Deviation 0.7
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)PROMIS Emotional Distress Anxiety Short Form 6a. 6 items. Range 6-30. Higher score indicates greater anxiety symptoms.
Outcome measures
| Measure |
Mindful After Cancer
n=21 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Anxiety at 1 Month
T1 Mean, SD
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15.0 score on a scale
Standard Deviation 5.4
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Change From Baseline Anxiety at 1 Month
T2 Mean, SD
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12.9 score on a scale
Standard Deviation 4.4
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)Center for Epidemiologic Studies Depression Scale (CES-D). 20 items. Range 0-60. Higher score indicates greater depressive symptoms
Outcome measures
| Measure |
Mindful After Cancer
n=20 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Depression at 1 Month
T1 Mean, SD
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16.3 score on a scale
Standard Deviation 9.0
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Change From Baseline Depression at 1 Month
T2 Mean, SD
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13.9 score on a scale
Standard Deviation 11.3
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)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.
Outcome measures
| Measure |
Mindful After Cancer
n=20 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change in Facets of Baseline Mindfulness at 1 Month
Observe subscale T1 Mean, SD
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10.8 score on a subscale
Standard Deviation 2.1
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Change in Facets of Baseline Mindfulness at 1 Month
Observe subscale T2 Mean, SD
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9.6 score on a subscale
Standard Deviation 0.9
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Change in Facets of Baseline Mindfulness at 1 Month
Acting with Awareness subscale T1 Mean, SD
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9.3 score on a subscale
Standard Deviation 2.0
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Change in Facets of Baseline Mindfulness at 1 Month
Non-reactivity subscale T1 Mean, SD
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9.7 score on a subscale
Standard Deviation 2.4
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Change in Facets of Baseline Mindfulness at 1 Month
Non-reactivity subscale T2 Mean, SD
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8.9 score on a subscale
Standard Deviation 1.0
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Change in Facets of Baseline Mindfulness at 1 Month
Non-judging subscale T1 Mean, SD
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10.7 score on a subscale
Standard Deviation 2.4
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Change in Facets of Baseline Mindfulness at 1 Month
Non-judging subscale T2 Mean, SD
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8.8 score on a subscale
Standard Deviation 1.4
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Change in Facets of Baseline Mindfulness at 1 Month
Describing subscale T1 Mean, SD
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10.3 score on a subscale
Standard Deviation 2.4
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Change in Facets of Baseline Mindfulness at 1 Month
Describing subscale T2 Mean, SD
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10.0 score on a subscale
Standard Deviation 1.5
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Change in Facets of Baseline Mindfulness at 1 Month
Acting with Awareness subscale T2 Mean, SD
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10.8 score on a subscale
Standard Deviation 2.2
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)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.
Outcome measures
| Measure |
Mindful After Cancer
n=20 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Self-compassion at 1 Month
T1 Mean, SD
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3.0 mean score on a scale
Standard Deviation 0.7
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Change From Baseline Self-compassion at 1 Month
T2 Mean, SD
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2.9 mean score on a scale
Standard Deviation 0.2
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SECONDARY outcome
Timeframe: Baseline (T1) and 1 month post-intervention (T2)Dyadic Adjustment Scale short form (DAS-7). Range 0-36. Higher score indicates more positive relationship quality
Outcome measures
| Measure |
Mindful After Cancer
n=14 Participants
Participants will be asked to attend 8 weekly sessions via videoconference, and to complete home activities and mindfulness practice between sessions.
Mindful 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.
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Change From Baseline Relationship Quality at 1 Month
T1 Mean, SD
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24.0 score on a scale
Standard Deviation 6.5
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Change From Baseline Relationship Quality at 1 Month
T2 Mean, SD
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25.3 score on a scale
Standard Deviation 5.7
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Adverse Events
Mindful After Cancer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place