NCT03936400

Brief Summary

The main purpose of the doctoral study is to better understand the experience of cancer diagnosis and treatment in how it effects sexuality and intimacy of the female cancer patient and her partner.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Apr 2017

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2017

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed
Last Updated

November 22, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

April 10, 2019

Last Update Submit

November 21, 2019

Conditions

Cancer

Keywords

cancerfemalespartners

Outcome Measures

Primary Outcomes (28)

  • Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1).

    This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

    T1 ( at baseline).

  • Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T2).

    This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

    T2 (1-2 weeks after baseline).

  • Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T3).

    This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

    T3 (3 months after baseline).

  • Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in control group (T1).

    This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

    T1 (at baseline).

  • Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2).

    This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

    T2 (wait-pre-intervention, 1 month after baseline).

  • Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T3).

    This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

    T3 (post-intervention, 1-2 weeks from T2).

  • Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T4).

    This questionnaire is a survivor self-report that screens for sexual concerns after cancer.

    T4 (post-intervention, 3 months from T3).

  • Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in experimental group (T1).

    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

    T1 (at baseline).

  • Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2).

    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

    T2 (1-2 weeks after baseline).

  • Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3).

    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

    T3 (3 months after baseline).

  • Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in control group (T1).

    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

    T1 (at baseline).

  • Partnership Questionnaire (PFB; Partnerschaftsfragebogen) pre-intervention in control group (T2).

    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

    T2 (wait-pre-intervention, 1 month after baseline).

  • Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T3).

    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

    T3 (post-intervention, 1-2 weeks from T2).

  • Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4).

    This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.

    T4 (post-intervention, 3 months from T3).

  • ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in experimental group (T1).

    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

    T1 ( at baseline).

  • ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T2).

    he instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

    T2 (1-2 weeks after baseline).

  • ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T3).

    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

    T3 (3 months after baseline).

  • ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).

    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

    T1 (at baseline).

  • ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2).

    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

    T2 (wait-pre-intervention, 1 month after baseline).

  • ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T3).

    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

    T3 (post-intervention, 1-2 weeks from T2).

  • ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T4).

    The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).

    T4 (post-intervention, 3 months from T3).

  • The Illness Intrusiveness Rating Scale (IIRS) at baseline in experimental group (T1).

    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

    T1 ( at baseline).

  • The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T2).

    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

    T2 (1-2 weeks after baseline).

  • The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T3).

    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

    T3 (3 months after baseline).

  • The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1).

    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

    T1 (at baseline).

  • The Illness Intrusiveness Rating Scale (IIRS) pre-intervention in control group (T2).

    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

    T2 (wait-pre-intervention, 1 month after baseline).

  • The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3).

    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

    T3 (post-intervention, 1-2 weeks from T2).

  • The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4).

    Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.

    T4 (post-intervention, 3 months from T3).

Study Arms (2)

Randomized controlled trial

EXPERIMENTAL

Experimental group receiving a couple-based intervention

Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy

Active comparator: control group

ACTIVE COMPARATOR

A control group that receives same but delayed couple-based intervention

Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy

Interventions

Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacyBEHAVIORAL

Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)

Active comparator: control groupRandomized controlled trial

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemales (hetrosexual, homosexual) and their partners.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All females, 18 yrs and older, diagnosed with cancer (all types) and their partners
  • Have began cancer treatment (surgical treatment, chemotherapy, radiation) - Are in a couple relationship
  • Live in Iceland and are able to travel to site of intervention
  • Speak and write Icelandic

You may not qualify if:

  • Single females
  • Do not read or write nor speak Icelandic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iceland, School of Health Sciences, Faculty of Nursing

Reykjavik, 101, Iceland

Location

Related Publications (2)

  • Jonsdottir JI, Vilhjalmsson R, Svavarsdottir EK. Effectiveness of a couple-based intervention on sexuality and intimacy among women in active cancer treatment: A quasi-experimental study. Eur J Oncol Nurs. 2021 Jun;52:101975. doi: 10.1016/j.ejon.2021.101975. Epub 2021 May 11.

    PMID: 34020136DERIVED

  • Jonsdottir JI, Vilhjalmsson R, Svavarsdottir EK. The Benefit of a Couple-Based Intervention Among Women in Active Cancer Treatment on Sexual Concerns: A Quasi-Experimental Study. Cancer Nurs. 2021 Nov-Dec 01;44(6):E589-E599. doi: 10.1097/NCC.0000000000000949.

    PMID: 33899783DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Ása Þórisdóttir, PhD

    University of Iceland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 10, 2019

First Posted

May 3, 2019

Study Start

April 15, 2017

Primary Completion

August 20, 2019

Study Completion

August 20, 2019

Last Updated

November 22, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

IC(1)