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Pilot Study of an Intimacy Enhancement Intervention for Couples Facing Breast Cancer

24 ottobre 2018 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

89

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19111
        • Fox Chase Cancer Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  1. Female
  2. Age > 21 years
  3. Has diagnosis of non-recurrent stage I-III breast cancer
  4. Completed active treatment (e.g., chemotherapy, radiation therapy, surgery) 6 months-5 years ago (current use of endocrine therapy is acceptable)
  5. Has a partner or spouse who is > 21
  6. Lives with a romantic partner > 6 months
  7. Score of > 3 on Patient Care Monitor Sexual Concerns screening item
  8. No hearing impairment in patient or partner

Exclusion Criteria:

  1. Not able to speak English, as stated in medical record or as observed by study team member
  2. ECOG Performance score > 2 OR too ill to participate as judged by physician/in medical record
  3. 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.
  4. Past history of any cancer other than non-melanoma skin cancer
  5. Currently participating in couple/marital therapy
  6. Currently pregnant

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Comportamentale: Partner-Assisted Coping Skills Training
Receive couple-based intimacy enhancement intervention
Comparatore attivo: 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.
Comportamentale: 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.
Comportamentale: Behavioral, Psychological or Informational Intervention
Receive educational information and support

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of the Treatment as Measured Through Study Accrual
Lasso di tempo: Up to 8 weeks
Feasibility is measured through the percentage of study eligible individuals who enrolled in the intervention study (i.e., acceptance rate).
Up to 8 weeks
Feasibility of the Treatment as Measured Through Study Attrition
Lasso di tempo: Up to 8 weeks
Feasibility of treatment is measured through the number of randomized participants who completed the study.
Up to 8 weeks
Feasibility of the Treatment as Measured Through Session Completion by Participant
Lasso di tempo: Up to 8 weeks
Feasibility of the treatment as measured through number of randomized participants who completed all 4 telephone sessions.
Up to 8 weeks
Acceptability Measured Using the Client Satisfaction Questionnaire (CSQ-8)
Lasso di tempo: Up to 8 weeks
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.
Up to 8 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Sexual Function Measured Using the Female Sexual Function Index (FSFI)
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Sexual Function Measured Using the International Index of Erectile Function
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Sexual Satisfaction Measured Using the Patient-Reported-Outcomes Measurement Information System (PROMIS) Sexual Satisfaction Items
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Sexual Distress Measured Using the Female Sexual Distress Scale-Revised
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Beliefs (Self-efficacy)
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Emotional Intimacy Measured Using the Personal Assessment of Intimacy in Relationships (PAIR) Emotional Intimacy Scale
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Sexual Communication Measured Using the Dyadic Sexual Communication Scale
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Relationship Quality Measured Using the Dyadic Adjustment Scale-7 Item
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Body Image Distress Measured Using the Body Image Scale
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Depression Measured Using the Patient Health Questionnaire-9 Item
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Anxiety Measured Using the Generalized Anxiety Disorder 7-item
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks
Change in Cancer-related Distress Using the Impact of Events Scale-Revised
Lasso di tempo: Baseline to up to 8 weeks
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.
Baseline to up to 8 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fox Chase Cancer Center

Collaboratori

National Cancer Institute (NCI)

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 ottobre 2015

Completamento primario (Effettivo)

29 settembre 2017

Completamento dello studio (Effettivo)

29 settembre 2017

Date di iscrizione allo studio

Primo inviato

14 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

28 marzo 2016

Primo Inserito (Stima)

29 marzo 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

25 ottobre 2018

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 ottobre 2018

Ultimo verificato

1 ottobre 2018

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 15-8007
  • 1R21CA191354-01 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

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INDECISO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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