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Couple therapy for cancer survivors.


- candidate number21133
- NTR NumberNTR4953
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-dec-2014
- Secondary IDsNOU 2013-6204 
- Public TitleCouple therapy for cancer survivors.
- Scientific TitleCouple therapy for cancer survivors: A prospective, randomized controlled study.
- ACRONYMCODA
- hypothesisColorectal cancer (CRC) is the third most prevalent form of cancer in the Netherlands. There is evidence that specific relational problems and impairment in sexual functioning are a prevalent complication of CRC and its treatment. In the general population, Emotion-Focused Couple Therapy (EFCT) for relational problems has been demonstrated to be very effective. Also, Adjuvant Online Digital Assistance (ODA) can enhance the effects of psychotherapy for diverse psychosocial problems, including relational problems. ODA can be delivered in the privacy of one's home where the intended behavioral changes in relational communication need to be implemented. ODA offers tailored suggestions, dependent on the answers given on a short questionnaire, collected using Experience Sampling Methodology (ESM). This study will evaluate the efficacy and cost-effectiveness of EFCT, in a blended form of face-to-face therapeutic sessions combined with ODA (EFCT-ODA) in a group of colorectal patients who successfully completed cancer treatment. It is hypothesized that the EFCT-ODA group, compared to a waiting-list control group, will significantly increase dyadic coping and relational satisfaction, improve perceived intimacy, sexual functioning, sexual distress and sexual satisfaction, supportive sexual communication, body image, psychological distress, and generic health-related quality of life and will prove to be a cost-effective intervention.
- Healt Condition(s) or Problem(s) studiedColorectal cancer, Emotion-focused-therapy, Partnerrelationship, Web-based Online Digital Assistance
- Inclusion criteria- Diagnosis of colon or rectal cancer
- Primary cancer treatment was completed between 12 months and 5 years earlier; no recurrence of cancer was diagnosed
- Aged between 18 and 75 years
- Has a partner relationship of at least three months duration
- Screened positively for distressing relational dissatisfaction or low dyadic coping
- Both patient and partner are interested in undergoing counseling
- Exclusion criteria- Major psychopathology of either partner (BSI Total score of 0.85 or higher)
- Lack of basic proficiency in the Dutch language
- No access to Internet
- Participation in concurrent treatment to alleviate relational problems
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2015
- planned closingdate1-sep-2017
- Target number of participants320
- InterventionsColorectal survivors in the experimental group will receive the intervention, which will consist of 12 face-to-face therapeutic EFT sessions, complemented with ODA. During treatment, the couple learns to recognize the cycle of defensive strategies that each partner uses to cope with threats. These strategies are validated and normalized, and not the person but the cycle is framed as the cause of the emotional problems and the issue that needs to be resolved. The therapist helps both partners to uncover the primary emotions that underlie their defensive strategies and to express these and their personal emotional needs in a more constructive way. Moreover, the adjuvant ODA offers tailored suggestions for behavioral actions to implement the EFCT elements into their daily lives. The ODA starts in the second half of the EFT therapy.
Participants in the waiting list control group will receive an empathetic telephone session with one of the study therapists in order to provide some control for a possible attention-placebo effect. For this same purpose, they will also receive a printed booklet with relevant questions about dyadic coping, relational functioning, intimacy and cancer. They are offered EFCT-ODA upon completion of post-treatment assessment.
- Primary outcome1. Dyadic coping
2. Marital Satisfaction

Dyadic coping will be measured with the Revised Dyadic Adjustment Scale (RDAS). The RDAS is a 14-item self-report measure of dyadic coping and relational adjustment in steady couples. Marital satisfaction will be measured with the Maudsley Marital Questionnaire (MMQ). The MMQ is a 20-item self-report questionnaire. Both primary outcomes will be assessed at all time points.
- Secondary outcome1. Sexual Functioning
2. Sexual distress
3. Health-Related Quality of Life
4. Psychological distress
5. Body image
6. Perceived intimacy
7. Supportive communication

Sexual functioning will be measured with the Profile of Sexual Function (PSF), a 35-item self-report measure. Sexual distress will be measured with the Sexual Distress Scale (SDS), a 12-item questionnaire to assess sexuality-related personal distress. Health-Related Quality of Life will be measured with the MOS SF-36 Health Survey (SF-36), a 36-item questionnaire which is organized into 8 multi-item scales. Psychological distress will be measured with the Brief Symptom Inventory-18 (BSI-18), an 18-item self-report symptom inventory that measures psychological distress. Body Image will be measured with the Body Image Scale (BIS). Perceived Intimacy will be measured with the Personal Assessment of Intimacy in Relationships (PAIR), a 36-item measure of intimacy, organized into 5 subscales. Finally, supportive communication will be measured with the Support Styles Questionnaire (SSQ), a 19-item self-report questionnaire to assess spousal supportive communication.
- TimepointsIn the experimental group, both primary and secondary outcomes will be measured at baseline (T0), post-treatment (T1) and at 6 months follow-up (T2). In the control group, both primary and secondary outcomes will be measured at baseline and post-treatment. After completing post-treatment assessment, participants allocated to the control group will be offered the full intervention, if desired. Control group patients who choose to undergo therapy will be asked to complete post-treatment assessment, and follow-up assessment after 6 months.
- Trial web sitecoda.ou.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc Audrey Beaulen
- CONTACT for SCIENTIFIC QUERIESProf. dr. J.J.D.M. van Lankveld
- Sponsor/Initiator Open University the Netherlands, Tilburg University, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
KWF Kankerbestrijding
- PublicationsN/A
- Brief summaryApproximately 40.000 men and women are diagnosed with either colorectal cancer, breast cancer or prostate cancer annually. Impaired relational and sexual functioning can be a consequence of these cancer forms and its treatment. Although cancer survivors with relational problems express interest in receiving professional help, relatively few receive face-to-face therapy. Therefore, in this study, colorectal, breast and prostate cancer survivors and their partners will be offered Emotionally-Focused Couple Therapy (EFCT), which is an effective form of therapy for relational problems. This face-to-face therapy will be complemented with adjuvant Online Digital assistance (ODA), which offers tailored suggestions based on the EFCT therapy. The Online Digital Assistance can enhance the effect of the face-to-face EFCT since it promotes behavioral changes in relational communication, not only during the therapy sessions, but also in the home setting. This study will evaluate the efficacy and cost-effectiveness of face-to-face EFCT complemented with Online Digital Assistance in a group of cancer survivors and their partners. We hypothesize that, compared to a waiting list control group:
1. Cancer survivors who receive the EFCT-ODA will report significantly greater improvement form baseline to post-treatment and 6 months follow-up in dyadic coping, and relational satisfaction
2. Cancer survivors exposed to the intervention will report significantly more improvement in sexual functioning, sexual distress and sexual satisfaction, perceived intimacy, supportive sexual communication, body image, psychological distress, and generic health-related quality of life
3. EFCT-ODA will prove to be a cost-effective intervention
- Main changes (audit trail)23-aug-2016: Amendement

Hypothesis NEW:
Colorectal , prostate and breast cancer are among the most prevalent forms of cancer in the Netherlands. There is evidence that specific relational problems and impairment in sexual functioning are a prevalent complication of these cancer forms and its treatment. In the general population, Emotionally-Focused Couple Therapy (EFCT) for relational problems has been demonstrated to be very effective. Also, adjuvant Online Digital Assistance (ODA) can enhance the effects of psychotherapy for diverse psychosocial problems, including relational problems. ODA can be delivered in the privacy of one's home where the intended behavioral changes in relational communication need to be implemented. ODA offers tailored suggestions, dependent on the answers given on a short questionnaire, collected using Experience Sampling Methodology (ESM). This study will evaluate the efficacy and cost-effectiveness of EFCT, in a blended form of face-to-face therapeutic sessions combined with ODA (EFCT-ODA) in a group of colorectal, prostate and breast cancer patients who successfully completed cancer treatment. It is hypothesized that the EFCT-ODA group, compared to a waiting-list control group, will significantly increase dyadic coping and relational satisfaction, improve perceived intimacy, sexual functioning, sexual distress and sexual satisfaction, supportive sexual communication, body image, psychological distress, and generic health-related quality of life and will prove to be a cost-effective intervention.

Inclusion criteria NEW:
- Diagnosis of colon or rectal cancer, prostate cancer or breast cancer
- Primary cancer treatment was completed between 12 months and 5 years earlier; no recurrence of cancer was diagnosed
- Aged between 18 and 75 years
- Has a partner relationship of at least three months duration
- Screened positively for distressing relational dissatisfaction or low dyadic coping
- Both patient and partner are interested in undergoing counseling

Exclusion criteria NEW:
- Major psychopathology of either partner - Lack of basic proficiency in the Dutch language
- No access to Internet
- Participation in concurrent treatment to alleviate relational problems

Interventions NEW:
Cancer survivors in the experimental group will receive the intervention, which will consist of 12 face-to-face therapeutic EFT sessions, complemented with ODA. During treatment, the couple learns to recognize the cycle of defensive strategies that each partner uses to cope with threats. These strategies are validated and normalized, and not the person but the cycle is framed as the cause of the emotional problems and the issue that needs to be resolved. The therapist helps both partners to uncover the primary emotions that underlie their defensive strategies and to express these and their personal emotional needs in a more constructive way. Moreover, the adjuvant ODA offers tailored suggestions for behavioral actions to implement the EFCT elements into their daily lives. The ODA starts in the second half of the EFT therapy. Participants in the waiting list control group will receive an empathetic telephone session with one of the researchers in order to provide some control for a possible attention-placebo effect. For this same purpose, they will also receive a digital or printed booklet with relevant questions about dyadic coping, relational functioning, intimacy and cancer. They are offered EFCT-ODA upon completion of post-treatment assessment.

Secondary outcome NEW:
1. Sexual Functioning
2. Sexual distress
3. Health-Related Quality of Life
4. Psychological distress
5. Body image
6. Perceived intimacy
7. Supportive communication

Sexual functioning will be measured with the Sexual Functioning Index (SFI), a 19-item self-report measure. Sexual distress will be measured with the Sexual Distress Scale (SDS), a 12-item questionnaire to assess sexuality-related personal distress. Health-Related Quality of Life will be measured with the MOS SF-36 Health Survey (SF-36), a 36-item questionnaire which is organized into 8 multi-item scales. Psychological distress will be measured with the Hospital Anxiety and Depression Scale (HADS), a 14-item self-report symptom inventory that measures psychological distress. Body Image will be measured with the Body Image Scale (BIS). Perceived Intimacy will be measured with the Personal Assessment of Intimacy in Relationships (PAIR), a 36-item measure of intimacy, organized into 5 subscales. Finally, supportive communication will be measured with the Support Styles Questionnaire (SSQ), a 19-item self-report questionnaire to assess spousal supportive communication.
- RECORD9-dec-2014 - 23-aug-2016


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