Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
14 november 2019 uppdaterad av: University of Wisconsin, Madison
Randomized-Controlled, Pilot Study of the Effects of a Brief, Scripted Sexual Health Intervention on Sexual Function for Women With Gynecologic Cancer
This randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer.
Discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants.
II. To determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population.
III. To establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention.
OUTLINE: Patients are randomized to 1 of 4 treatment arms.
ARM I: Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
ARM II: Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
ARM III: Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.
ARM IV: Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
Studietyp
Interventionell
Inskrivning (Faktisk)
15
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Wisconsin
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin, Madison
-
-
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
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Kvinna
Beskrivning
Inclusion Criteria:
- Patients with a new suspected or confirmed gynecologic malignancies
- Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
- Patients must be English speaking
Exclusion Criteria:
- Previous treatment of any cancer excluding skin cancer
- Patients with a suspected benign gynecologic process
- Patients who are prisoners or incarcerated
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: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Arm I (standard counseling)
Patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit.
|
Sidostudier
Given standard counseling
Andra namn:
|
|
Experimentell: Arm II (standard counseling, scripted intervention)
Patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit.
|
Sidostudier
Given standard counseling
Andra namn:
Given scripted intervention
|
|
Experimentell: Arm III (standard counseling, scripted intervention)
Patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit.
|
Sidostudier
Given standard counseling
Andra namn:
Given scripted intervention
|
|
Experimentell: Arm IV (standard counseling, scripted intervention)
Patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.
|
Sidostudier
Given standard counseling
Andra namn:
Given scripted intervention
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Feasibility of patient recruitment
Tidsram: Up to 9 months
|
To inform possible issues in recruitment for a large-scale randomized controlled trial, the ratio of enrolled subjects to total eligible potential subjects as well as the time necessary to recruit those subjects will be tracked.
|
Up to 9 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Resumption of sexual activity after cancer surgery
Tidsram: Up to 9 months
|
Resumption of sexual activity after cancer surgery will be measured using items adapted from a previous national, multi-site study of sexual outcomes following an acute myocardial infarction.
|
Up to 9 months
|
|
Retention
Tidsram: Up to 9 months
|
The percentage of subjects completing the final assessment from the total number of subjects enrolled will be calculated.
|
Up to 9 months
|
|
Satisfaction with sex life independent of specific sexual function measured by Patient Reported Outcomes Measurement Information System (PROMIS) Global Satisfaction with Sex Life questionnaire
Tidsram: Up to 9 months
|
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
|
Up to 9 months
|
|
PROMIS Sexual Function Profile
Tidsram: Up to 9 months
|
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
|
Up to 9 months
|
|
Recall of intervention
Tidsram: Up to 9 months
|
Subjects will be queried to learn whether they recall receiving physician counseling about sexual health outcomes after surgery with follow up questions regarding whether or not the patient has spoken with other healthcare providers about sexual concerns.
|
Up to 9 months
|
|
Patient-reported anxiety measured by PROMIS Anxiety 4a short form
Tidsram: Up to 6 months
|
Descriptive statistics will be used to summarize survey responses overall and separately for both the experimental and control arms.
|
Up to 6 months
|
|
Rate of referral acceptance
Tidsram: Up to 9 months
|
The rate of acceptance of sexual health clinic referrals as well as rates of utilization of these referrals will be tracked using medical record abstraction.
|
Up to 9 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: David Kushner, University of Wisconsin, Madison
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
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
1 september 2014
Primärt slutförande (Faktisk)
1 juni 2015
Avslutad studie (Faktisk)
1 juni 2016
Studieregistreringsdatum
Först inskickad
21 mars 2014
Först inskickad som uppfyllde QC-kriterierna
21 mars 2014
Första postat (Uppskatta)
26 mars 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
18 november 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 november 2019
Senast verifierad
1 november 2016
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Mentala störningar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Urogenitala neoplasmer
- Neoplasmer efter plats
- Carcinom
- Neoplasmer, körtel och epitel
- Uterina neoplasmer
- Genitala neoplasmer, hona
- Livmodersjukdomar
- Sjukdomar i det endokrina systemet
- Ovariella sjukdomar
- Adnexala sjukdomar
- Gonadal sjukdomar
- Neoplasmer i endokrina körtel
- Neoplasmer, könsceller och embryonala
- Graviditetskomplikationer
- Vaginala sjukdomar
- Vulva sjukdomar
- Ovariella neoplasmer
- Graviditetskomplikationer, neoplastiska
- Ångeststörningar
- Endometriella neoplasmer
- Karcinom, äggstocksepitel
- Vulva neoplasmer
- Trofoblastiska neoplasmer
- Vaginala neoplasmer
Andra studie-ID-nummer
- UW13080 (Annan identifierare: University of Wisconsin Carbone Cancer Center)
- P30CA014520 (U.S.S. NIH-anslag/kontrakt)
- A532820 (Annan identifierare: UW Madison)
- SMPH/OBSTET & GYNECOL/OBSTET (Annan identifierare: UW Madison)
- NCI-2014-00471 (Registeridentifierare: NCI Trial ID)
- 2014-0122 (Annan identifierare: Institutional Review Board)
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