Couple therapy for cancer survivors : A prospective, randomized controlled study.

Annualy, more than 40.000 men and women in the Netherlands are diagnosed with
colorectal, prostate and breast cancer. There is compelling evidence that
specific relational problems are a prevalent complication of these types of
cancer and its treatment. Impaired relational functioning can also have a
negative effect on intimacy (including mutual emotional support), on sexual
functioning and satisfaction, and on health-related quality of life (HRQoL).

In the general population, Emotion-Focused Couple Therapy (EFCT) for relational
problems has been demonstrated to be very effective. Steps in EFCT are: (1)
stabilization and de-escalation; (2) change; and (3) integration,
consolidation, and relapse prevention. To our knowledge, the efficacy of EFCT
has not be investigated among cancer survivors. Adjuvant Online Digital
Assistance (ODA) can enhance the effects of psychotherapy for various
psychosocial problems. It may be particularly attractive for relational
problems as it can be delivered within the privacy of one*s home where the
intended behavioral changes in relational communication need to be implemented.
ODA offers tailored suggestions, based on data collected with the Experience
Sampling Methodology (ESM). ESM is an ecologically valid method of assessment
in the natural environment. Both partners receive ODA advice through a
web-based assessment tool.

In this study, a group of cancer survivors and their partners will be offered
EFCT-ODA and will be compared with a waiting-list control group. It is
hypothesized that the EFCT-ODA group will show more dyadic coping and is more
satisfied with the relationship than the control group, as well on short term
as on long term (6 months follow-up). Moreover, it is hypothesized that sexual
functioning, perceived intimacy, body image, psychological wellbeing and
general health related quality of life will improve compared with the control
group.

The primary objective of the study is to gain insight in the short term and
long term effects of the EFCT-ODA therapy on 1) dyadic coping abilities in the
relationship and 2) relational satisfaction. Moreover, the process aspects of
the ODA will be evaluated.

The secondary objective of the study is to gain insight in the short term and
long term effects of the EFCT-ODA therapy on the level of experienced intimacy,
sexual functioning, sexual distress, sexual satisfaction, supportive sexual
communication, body image, psychological distress and generic health related
quality of life. Moreover, the secondary objective of the study is to
demonstrate whether the EFCT-ODA intervention is a cost-effective intervention.

In a randomised controlled trial (RCT), 160 cancer survivors and their partners
will be recruited in several hospitals in the Netherlands. Participants: 1)
have completed their primary treatment between 12 months and 5 years ago and
are disease free at study; 2) meet clinical criteria for relational functioning
problems, and be motivated to undergo therapy together with their partner.

Patients and their partners who show their interest in participating in the
study, will be screened by means of several questions to assess couple problems
regarding relational satisfaction, unsupportive communication, and low
perceived intimacy.
When at least the cancer survivor scores positive on any of these (relational
satisfaction, perceived intimacy, or supportive communication: low or very low)
questions, and when both patient and partner are motivated for participation,
the couple will be included in the study.

Included couples will be randomized by means of the minimization technique,
with cancer form, gender, time since diagnosis and treatment form as
stratification variables. The couples will be allocated to the EFCT-ODA group
or a waiting list control group (n = 80 pairs per group). EFCT will be executed
in 12 face-to-face sessions of 60-70 minutes. ODA will be provided on three
days per week.
The intervention group and the control group complete a questionnaire before
the start of the intervention (T0) as well as after the finish of the
intervention (T1). Only de intervention group will also complete a
questionnaire at 6-months follow-up (T2).

The control group will be offered the intervention after T1. The couples who
accept this offer, will be asked to complete a questionnaire directly after
finishing the intervention, as well as at 6-months follow-up.

Examine the study design in the overview below:

E: S * T0 * randomization * EFCT-ODA * T1 * T2
C: S * T0 * randomization * waiting list * T1 * EFCT-ODA * T1 * T2

E = experimental group
C = control group
S = screening
T0 = baseline questionnaire
Randomization = allocation to experimental or control group by means of
minimization technique
EFCT-ODA = Emotion Focused Couple Therapy with Online Digital Assistance
Waiting list = no intervention
T1 = first follow-up questionnaire after completing therapy
T2 = second follow-up questionnaire after 6 months

Couples in the intervention group will receive 12 sessions of Emotion Focused
Couple Therapy (EFCT), offered by a registered EFT therapist. This is the same
treatment for relation problems as is offered in regular health care. Emotion
Focused Couple Therapy has been demonstrated to be very effective in the
general population. Steps in EFCT are: 1) Stabilization and de-escalation; 2)
change; and 3) integration, consolidation and relapse prevention.
Couples will also be asked to fill in a short questionnaire through the
internet using Experience Sampling Methodology (ESM) during 3 days a week.
During the second half of the therapy, couples might receive tailored advice or
assignments that match the EFCT therapy. It is assumed that this will increase
the treatment effect.

Couples in the control group will not be offered the EFCT-ODA intervention
during the study, but afterwards (waiting list control group).

There are no risks and detrimental consequences associated with participating
in the study. Participant will receive the same therapy which is offered to
couples with relational problems in the regular health care. Moreover, all the
participants (in the experimental group and in
the control group) can stop their participation in the study at any time.
The burden of completing a questionnaire twice or three times in a year is low.
The burden of following the EFCT therapy is higher, but it is expected that
this form of relational therapy will have beneficial consequences, among other
things satisfaction with the (sexual) relationship. Participants will be
offered this intervention free of charge.
The questionnaires that have to be completed by the intervention group through
the internet are very short and take only a small amount of time to complete.
Moreover, it is expected that it will enhance the positive therapeutic effect.
Participants won't be refrained from care. The only exception is that they will
be asked to refrain from therapeutic relationship counseling during the study
period.