Clinical trial NCT03936400: Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners
Official title: Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: cancer
females
partners
Lead sponsor: University of Iceland
Sponsor class: OTHER
Collaborators: name: Landspitali University Hospital
First posted: 2019-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: With this increased understanding, an intervention, comprised of therapeutic interventions with the couple, will be conducted and assessed on how it affects the couple's general well-being and recovery of the sexual and intimate relationship.

The intervention consists of three therapeutic conversations, based on the Illness Beliefs model in family nursing, and an optional web-based evidence based information. The aim of the intervention is to support the facilitating beliefs of the couple in adapting to changes in intimacy and identify constraining beliefs. In the first session an emphasis is on creating an optimal context for changing beliefs by building good therapeutic relationship and to invite them to share their experience, giving them the opportunity to voice their own concerns and reflect on how their situation effects their intimate relationship. In the second session, the couple take a closer look at what they themselves deem important in adjusting to changes in their intimate relationship. In both sessions information about the possible sexual side effects of treatment will be offered as needed and evidence based, optional web-based information on practical solutions will be provided. In the booster-session, the couple will assess how they have been adjusting in their intimate relationship and any positive changes that have occurred will be accentuated.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1).
timeFrame: T1 ( at baseline).
measure: Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T2).
timeFrame: T2 (1-2 weeks after baseline).
measure: Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T3).
timeFrame: T3 (3 months after baseline).
measure: Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in control group (T1).
timeFrame: T1 (at baseline).
measure: Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2).
timeFrame: T2 (wait-pre-intervention, 1 month after baseline).
measure: Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T3).
timeFrame: T3 (post-intervention, 1-2 weeks from T2).
measure: Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T4).
timeFrame: T4 (post-intervention, 3 months from T3).
measure: Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in experimental group (T1).
timeFrame: T1 (at baseline).
measure: Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2).
timeFrame: T2 (1-2 weeks after baseline).
measure: Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3).
timeFrame: T3 (3 months after baseline).
measure: Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in control group (T1).
timeFrame: T1 (at baseline).
measure: Partnership Questionnaire (PFB; Partnerschaftsfragebogen) pre-intervention in control group (T2).
timeFrame: T2 (wait-pre-intervention, 1 month after baseline).
measure: Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T3).
timeFrame: T3 (post-intervention, 1-2 weeks from T2).
measure: Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4).
timeFrame: T4 (post-intervention, 3 months from T3).
measure: ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in experimental group (T1).
timeFrame: T1 ( at baseline).
measure: ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T2).
timeFrame: T2 (1-2 weeks after baseline).
measure: ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T3).
timeFrame: T3 (3 months after baseline).
measure: ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).
timeFrame: T1 (at baseline).
measure: ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2).
timeFrame: T2 (wait-pre-intervention, 1 month after baseline).
measure: ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T3).
timeFrame: T3 (post-intervention, 1-2 weeks from T2).
measure: ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T4).
timeFrame: T4 (post-intervention, 3 months from T3).
measure: The Illness Intrusiveness Rating Scale (IIRS) at baseline in experimental group (T1).
timeFrame: T1 ( at baseline).
measure: The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T2).
timeFrame: T2 (1-2 weeks after baseline).
measure: The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T3).
timeFrame: T3 (3 months after baseline).
measure: The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1).
timeFrame: T1 (at baseline).
measure: The Illness Intrusiveness Rating Scale (IIRS) pre-intervention in control group (T2).
timeFrame: T2 (wait-pre-intervention, 1 month after baseline).
measure: The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3).
timeFrame: T3 (post-intervention, 1-2 weeks from T2).
measure: The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4).
timeFrame: T4 (post-intervention, 3 months from T3).
Secondary outcomes:
Other outcomes:
Locations:
city: Reykjavík
country: Iceland
facility: University of Iceland, School of Health Sciences, Faculty of Nursing
Study officials:
affiliation: University of Iceland
name: Ása Þórisdóttir, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.