Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer
24 oktober 2018 uppdaterad av: Fox Chase Cancer Center
The central goal of this study is to examine the feasibility, acceptability, and preliminary efficacy of the IE intervention on patient and partner sexual QOL and relationship outcomes, and on patient psychosocial outcomes.
We expect that the IE will show adequate feasibility, acceptability, and preliminary efficacy.
Secondarily, based on the rationale that barriers exist that limit participation in intensive sexual QOL interventions for breast cancer survivors, an innovative secondary aim will investigate the perspectives of study-eligible patient candidates who opt out of participating in the pilot trial.
We expect that we will be able to identify the participation barriers and intervention preferences of breast cancer survivors with sexual concerns who opt out of the intensive trial in order to inform the development of different interventions for future study.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
89
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
21 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Female
- Age > 21 years
- Has diagnosis of non-recurrent stage I-III breast cancer
- Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
- Has a partner or spouse who is > 21
- Lives with a romantic partner > 6 months
- Score of > 3 on Patient Care Monitor Sexual Concerns screening item
- No hearing impairment in patient or partner
Exclusion Criteria:
- Not able to speak English, as stated in medical record or as observed by study team member
- ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
- Overt cognitive dysfunction or psychiatric disturbance such as suicidal ideation or severe mental illness, as observed or judged by the researcher, referring source, or other qualified observer.
- Past history of any cancer other than non-melanoma skin cancer
- Currently participating in couple/marital therapy
- Currently pregnant
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Intimacy Enhancing Intervention
Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
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Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks.
The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges.
Participants are encouraged to participate in written and behavioral activities at home.
Receive couple-based intimacy enhancement intervention
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Aktiv komparator: Living Healthy Together
Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
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Participants receive educational information and support about breast cancer every other week for 4 weeks.
The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet.
Participants are encouraged to read educational materials.
Receive educational information and support
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Feasibility of the Treatment as Measured Through Study Accrual
Tidsram: Up to 8 weeks
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Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
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Up to 8 weeks
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Feasibility of the Treatment as Measured Through Study Attrition
Tidsram: Up to 8 weeks
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Feasibility of treatment is measured through the number of randomized participants who completed the study.
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Up to 8 weeks
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Feasibility of the Treatment as Measured Through Session Completion by Participant
Tidsram: Up to 8 weeks
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Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
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Up to 8 weeks
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Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
Tidsram: Up to 8 weeks
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Acceptability was measured through the median score on a validated acceptability measure.
Item responses run on a scale of 1 to 4, with a total score range of 8-32.
Higher scores indicate higher satisfaction with the service (acceptability).
A median score of 28 or higher is considered acceptable.
This measure was collected for both patients and partners.
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Up to 8 weeks
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 2 to 36.
Higher scores indicate higher level of functioning.
Change in mean patient FSFI score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Function Measured Using the International Index of Erectile Function
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 1 to 75, with higher scores indicating a higher level of sexual functioning.
Change in mean male partner IIEF score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual functioning from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
Tidsram: Baseline to up to 8 weeks
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The PROMIS uses T-scores that are calculated against U.S. population norms with a M of 50 and SD of 10.
Higher T-scores indicate higher levels of sexual satisfaction.
Change in sexual satisfaction T-scores from pre-intervention to post-intervention are reported.
Positive change scores indicate increase in sexual satisfaction from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 0 to 52.
Higher scores indicate higher levels of sexual distress.
Change in patient mean sexual distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in sexual distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Beliefs (Self-efficacy)
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 0 to 100.
Higher scores indicate higher degree of self-efficacy for coping with sexual concerns.
Change in mean self-efficacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in self-efficacy from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 1 to 5. Higher scores indicate higher level of emotional intimacy with one's partner.
Change in mean emotional intimacy score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in emotional intimacy from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 13 to 78.
Higher scores indicate more communication.
Change in mean sexual communication score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in sexual communication from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 0 to 36.
Higher scores indicate higher relationship quality.
Change in mean relationship quality score from pre-intervention to post-intervention is reported.
Positive mean change scores indicate increase in relationship quality from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Body Image Distress Measured Using the Body Image Scale
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 0 to 30.
Higher scores indicate higher level of body image distress.
Change in mean body image distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in body image distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Depression Measured Using the Patient Health Questionnaire-9 Item
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 0 to 27.
Higher scores indicate higher level of depression.
Change in mean depression score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in depression from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 0 to 21.
Higher scores indicate higher levels of anxiety.
Change in mean anxiety score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in anxiety from pre- to post-intervention.
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Baseline to up to 8 weeks
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Change in Cancer-related Distress Using the Impact of Events Scale-Revised
Tidsram: Baseline to up to 8 weeks
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Total scale scores range from 0 to 88.
Higher scores indicate higher levels of distress.
Change in mean cancer-related distress score from pre-intervention to post-intervention is reported.
Negative mean change scores indicate decrease in distress from pre- to post-intervention.
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Baseline to up to 8 weeks
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
27 oktober 2015
Primärt slutförande (Faktisk)
29 september 2017
Avslutad studie (Faktisk)
29 september 2017
Studieregistreringsdatum
Först inskickad
14 mars 2016
Först inskickad som uppfyllde QC-kriterierna
28 mars 2016
Första postat (Uppskatta)
29 mars 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
25 oktober 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
24 oktober 2018
Senast verifierad
1 oktober 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15-8007
- 1R21CA191354-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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