Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners

Study Overview
=================
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.

Official Title
-----------------
Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Randomized controlled trial<br>Experimental group receiving a couple-based intervention | Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy<br>* Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)<br>|
| Active Comparator: Active comparator: control group<br>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<br>* Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, females, partners