CancerNCT03936400
Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners
A study testing Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy in people with Cancer, run by Erla Kolbrún Svavarsdóttir at 1 site in Iceland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIceland
- Study dates
- 15 Apr 2017to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Single females
- Do not read or write nor speak Icelandic
Trial locations and contacts
1 site in 1 country.
Iceland1 site
University of Iceland, School of Health Sciences, Faculty of Nursing
Reykjavik, 101
About this study
Official title: Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy
- Keywords
- cancer, females, partners
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacyBehavioural
Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)
| Study group | Role | What they receive |
|---|---|---|
| Randomized controlled trial | Experimental | Experimental group receiving a couple-based intervention Receives: 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 Receives: Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T4 (post-intervention, 3 months from T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2019
- Study start15 Apr 2017
- Primary completion20 Aug 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erla Kolbrún Svavarsdóttir
- Sponsor type
- University, hospital or other
- Collaborators
- Landspitali University Hospital
- Responsible party
- Sponsor-investigator, Erla Kolbrún Svavarsdóttir, University of Iceland
- Investigators
- Ása Þórisdóttir, PhD, Study chair, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03936400
- Sponsor's protocol ID
- UIceland-22019JIJ
- Status last verified
- Nov 2019
- First submitted
- 10 Apr 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34020136Jonsdottir 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.
PubMed 33899783
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Therapeutic Conversations With Females Diagnosed With Cancer and Their Partners: Evaluation of Effectiveness in Adjustment of Sexuality and Intimacy
- ClinicalTrials.gov ID
- NCT03936400
- Acronym / sponsor ID
- UIceland-22019JIJ
- Conditions
- Cancer
- Keywords
- cancer, females, partners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Erla Kolbrún SvavarsdóttirUniversity, hospital or other
- Collaborators
- Landspitali University Hospital
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 3 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Randomized controlled trial | Experimental | Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacyExperimental group receiving a couple-based intervention |
| Active comparator: control group | Active comparator | Behavioral: Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacyA control group that receives same but delayed couple-based intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Single females
- Do not read or write nor speak Icelandic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacyThree face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment) | Behavioural | Active comparator: control group, Randomized controlled trial |
Primary outcome
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1).
Time frame: T1 ( at baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T2).
Time frame: T2 (1-2 weeks after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in experimental group (T3).
Time frame: T3 (3 months after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in control group (T1).
Time frame: T1 (at baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) pre-intervention in control group (T2).
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T3).
Time frame: T3 (post-intervention, 1-2 weeks from T2).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) post-intervention in control group (T4).
Time frame: T4 (post-intervention, 3 months from T3).
This questionnaire is a survivor self-report that screens for sexual concerns after cancer.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in experimental group (T1).
Time frame: T1 (at baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T2).
Time frame: T2 (1-2 weeks after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in experimental group (T3).
Time frame: T3 (3 months after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) at baseline in control group (T1).
Time frame: T1 (at baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) pre-intervention in control group (T2).
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T3).
Time frame: T3 (post-intervention, 1-2 weeks from T2).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
Partnership Questionnaire (PFB; Partnerschaftsfragebogen) post-intervention in control group (T4).
Time frame: T4 (post-intervention, 3 months from T3).
This 30-item questionnaire was developed for diagnosis and evaluation in conjoint marital therapy.
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in experimental group (T1).
Time frame: T1 ( at baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T2).
Time frame: T2 (1-2 weeks after baseline).
he instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in experimental group (T3).
Time frame: T3 (3 months after baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) at baseline in control group (T1).
Time frame: T1 (at baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) pre-intervention in control group (T2).
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T3).
Time frame: T3 (post-intervention, 1-2 weeks from T2).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
ICE-Beliefs questionnaire for couples (ICE-COUPLE) post-intervention in control group (T4).
Time frame: T4 (post-intervention, 3 months from T3).
The instrument measures changes in facilitating or constraining beliefs through Therapeutic conversation intervention (TCI).
The Illness Intrusiveness Rating Scale (IIRS) at baseline in experimental group (T1).
Time frame: T1 ( at baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T2).
Time frame: T2 (1-2 weeks after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in experimental group (T3).
Time frame: T3 (3 months after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) at baseline in control group (T1).
Time frame: T1 (at baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) pre-intervention in control group (T2).
Time frame: T2 (wait-pre-intervention, 1 month after baseline).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T3).
Time frame: T3 (post-intervention, 1-2 weeks from T2).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
The Illness Intrusiveness Rating Scale (IIRS) post-intervention in control group (T4).
Time frame: T4 (post-intervention, 3 months from T3).
Illness Intrusiveness Rating Scale (IIRS) measures the extent to which disease and/or its treatment interferes with lifestyles, activities and interests.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Derived from this study: PubMed 34020136Jonsdottir 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.
- Derived from this study: PubMed 33899783Jonsdottir 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ása Þórisdóttir, PhD study chair
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy in people with Cancer, run by Erla Kolbrún Svavarsdóttir at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Concerns Questionnaire-Gynecological Cancer (SCQ-GC) at baseline in experimental group (T1). (time frame: T1 ( at baseline).). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03936400, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.